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D001424: Bacterial Infections

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (9)


Name (Synonyms) Correlation
drug662 COVID-19 infection status Wiki 0.71
drug1064 Digoxin Wiki 0.71
drug795 Cimetidine Wiki 0.71
Name (Synonyms) Correlation
drug2548 Placebo matching to gepotidacin Wiki 0.71
drug1400 Gepotidacin Wiki 0.71
drug1349 Fosfomycin disodium Wiki 0.71
drug2894 Rifampicin Wiki 0.50
drug663 COVID-19 pandemic Wiki 0.50
drug2044 Midazolam Wiki 0.32

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D003141 Communicable Diseases NIH 0.05
D007239 Infection NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

Clinical Trials

Navigate: Correlations   HPO

There are 2 clinical trials


1 A Phase 1 Safety and Intrapulmonary Pharmacokinetics Study of ZTI-01 (Intravenous Fosfomycin Disodium) in Healthy Adult Subjects

This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window). A total of 30 enrolled subjects will be randomized to undergo a single standardized bronchoscopy with bronchoalveolar lavage (BAL) at one of five sampling times. A total of 6 subjects will be assigned to each BAL-sampling time. Up to ten additional enrolled subjects will act as alternates to obtain 30 evaluable subjects. An evaluable subject is defined as a subject who receives all doses of ZTI-01, undergoes BAL at the randomized sampling timepoint with BAL return volume adequate for testing, and undergoes at least the one blood sampling timepoint that is concurrent with the assigned BAL sampling timepoint, with blood sampling volume that is adequate for testing. The objectives of the study are to assess safety and pharmacokinetics (PK) for a multiple dose regimen of IV-infused ZTI-01.

NCT03910673
Conditions
  1. Bacterial Infection
  2. Multiple-drug Resistance
  3. Pathogen Resistance
Interventions
  1. Drug: Fosfomycin disodium
MeSH:Bacterial Infections

Primary Outcomes

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Area under the concentration vs. time curve (AUC0-8 and AUC0-infinity) for ZTI -01

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study

Measure: Clearance (CL) of ZTI-01

Time: Day 1 to Day 2

Description: Defined as percent penetration of lung epithelial lining fluid (ELF) and alveolar macrophages (AMs). The ratios of ELF and AM concentrations of fosfomycin to simultaneous plasma concentrations will be calculated for each subject and summarized for each sampling time. The median concentrations of fosfomycin from the BAL sampling times will be used to estimate the AUC0-8 of plasma, ELF, and AM. The ratio of AUC0-8 of ELF-to-plasma and AM-to-plasma will be calculated to determine the percent penetration.

Measure: Intrapulmonary pharmacokinetics of ZTI-01

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Maximum measured plasma concentration (Cmax) of ZTI-01

Time: Day 1 to Day 2

Description: Clinical laboratory evaluations include serum chemistry (albumin, glucose, blood urea nitrogen (BUN), potassium, magnesium, calcium, sodium, total protein, creatinine, triglycerides, total cholesterol, creatine phosphokinase (CPK), phosphorus, alkaline phosphatase (ALP), AST, ALT, total bilirubin, direct bilirubin, and lactate dehydrogenase (LDH)), hematology (CBC with differential (hemoglobin, hematocrit, platelet count, white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, basophils)), coagulation (PT and aPTT), urinalysis (leukocyte esterase, blood, pH, specific gravity, glucose, protein), and plasma urea concentration.

Measure: Number of participants experiencing abnormal clinical laboratory assessments compared to baseline

Time: Day 1 to Day 2

Description: Physical exams will include assessment of skin, head and neck, lungs, heart, liver, spleen, extremities, lymph nodes, musculoskeletal system/extremities, abdomen, nervous system, weight, height, and body mass index (BMI).

Measure: Number of participants experiencing abnormal physical examination findings compared to baseline

Time: Day 1 to Day 2

Description: Vital sign measurements will include heart rate, blood pressure, temperature, respiratory rate, and peripheral oxygen saturation.

Measure: Number of participants experiencing abnormal vital sign measurements compared to baseline

Time: Day 1 to Day 2

Measure: Number of participants experiencing adverse events (AEs)

Time: Day 1 to Day 3

Description: QTc, PR, and QRS intervals are expressed in milliseconds (msec).

Measure: Number of participants with prolonged QTc, PR, or QRS interval in electrocardiogram (ECG) readings

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Terminal elimination half-life (t1/2) of ZTI-01

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Terminal-phase elimination rate constant (lambdaz) of ZTI-01

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Time to peak concentration (Tmax) of ZTI-01

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Volume of ZTI-01 distribution (Vd)

Time: Day 1 to Day 2
2 A Pharmacokinetic, Multi-cohort Study in Healthy Adult Subjects to Assess Gepotidacin as Victim and as Perpetrator of Drug-Drug Interactions Via CYP450, Renal and Intestinal Transporters, and to Assess Gepotidacin Pharmacokinetics in Japanese Healthy Adults

This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability study in adult healthy participants, including Japanese cohort. This study is designed to assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and establishing PK and safety in Japanese participants in cohort 4. Food effect will also be evaluated in cohort 4.

NCT04493931
Conditions
  1. Bacterial Infections
  2. Infections, Bacterial
Interventions
  1. Drug: Gepotidacin
  2. Drug: Cimetidine
  3. Drug: Rifampicin
  4. Drug: Midazolam
  5. Drug: Digoxin
  6. Other: Placebo matching to gepotidacin
MeSH:Infection Communicable Diseases Bacterial Infections

Primary Outcomes

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Maximum observed concentration (Cmax) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Time to reach maximum observed plasma concentration (Tmax) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Terminal phase half-life (t1/2) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC [0-t]) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: AUC from time 0 (predose) extrapolated to infinite time (AUC[0-infinity]) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Cmax of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Lag time before observation of drug concentrations (Tlag) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Tmax of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-t) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-infinity) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: Cmax of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: Tlag of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: Tmax of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: AUC(0-t) of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: AUC(0-infinity) of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: Cmax of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: Tlag of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: Tmax of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: AUC(0-t) of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: AUC(0-infinity) of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Cmax of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tmax of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC from time 0 (predose) to 24 hours post dose administration (AUC [0-24]) of gepotidacin after a single 1500 mg dose

Time: Up to 24 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC from time 0 (predose) to 48 hours post dose administration (AUC [0-48]) of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-t) of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-infinity) of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Cmax of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tmax of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC from time 0 (predose) to time tau (AUC[0-tau]) of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Cmax of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tmax of gepotidacin after the second dose of 3000 mg gepotidacin (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-tau) of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Accumulation ratio for Cmax (RoCmax) of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of morning dose up to 48 hours post evening dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Accumulation ratio for AUC (RoAUC) of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of morning dose up to 48 hours post evening dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-24) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 24 hours post morning dose (first dose) in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-48) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 48 hours post morning dose (first dose) in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-t) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: AEs will be collected.

Measure: Cohort 4: Number of participants with non-serious adverse events (non-SAEs)

Time: Up to Day 16

Description: SAEs will be collected.

Measure: Cohort 4: Number of participants with serious adverse events (SAEs)

Time: Up to Day 16

Description: Number of participants with abnormal vital signs will be assessed.

Measure: Cohort 4: Number of participants with abnormal vital signs

Time: Up to Day 16

Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.

Measure: Cohort 4: Number of participants with abnormal electrocardiogram (ECG) findings

Time: Up to Day 16

Description: Blood samples will be collected for the assessment of hematology parameters.

Measure: Cohort 4: Number of participants with abnormal hematology parameters

Time: Up to Day 16

Description: Blood samples will be collected for the assessment of chemistry parameters.

Measure: Cohort 4: Number of participants with abnormal clinical chemistry parameters

Time: Up to Day 16

Description: Urine samples will be collected for the assessment of urinalysis parameters.

Measure: Cohort 4: Number of participants with abnormal urinalysis findings

Time: Up to Day 16

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Cmax of gepotidacin after a single 1500 mg dose under fed conditions

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tlag of gepotidacin after a single 1500 mg dose under fed conditions

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tmax of gepotidacin after a single 1500 mg dose under fed conditions

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-t) of gepotidacin after a single 1500 mg dose under fed conditions

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-infinity) of gepotidacin after a single 1500 mg dose under fed conditions

Time: Up to 48 hours post dose in Period 1 and Period 2

Secondary Outcomes

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: AUC(0-24) of gepotidacin

Time: Up to 24 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: AUC(0-48) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Tlag of a gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Apparent volume of distribution (Vz/F) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Apparent oral clearance (CL/F) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Total unchanged drug (Ae total) of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: AUC(0-24) of gepotidacin in urine

Time: Up to 24 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: AUC(0-48) of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Renal clearance of drug (CLr) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Amount of drug excreted in urine in a time interval (Ae[t1-t2]) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 1: Percentage of the given dose of drug excreted in urine (fe%) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: AEs will be collected.

Measure: Cohort 1: Number of participants with non-SAEs

Time: Up to Day 14

Description: SAEs will be collected.

Measure: Cohort 1: Number of participants with SAEs

Time: Up to Day 14

Description: Blood samples will be collected for the assessment of hematology parameters.

Measure: Cohort 1: Number of participants with abnormal hematology parameters

Time: Up to Day 14

Description: Blood samples will be collected for the assessment of chemistry parameters.

Measure: Cohort 1: Number of participants with abnormal clinical chemistry parameters

Time: Up to Day 14

Description: Urine samples will be collected for the assessment of urinalysis parameters.

Measure: Cohort 1: Number of participants with abnormal urinalysis findings

Time: Up to Day 14

Description: Number of participants with abnormal vital signs will be assessed.

Measure: Cohort 1: Number of participants with abnormal vital signs

Time: Up to Day 14

Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.

Measure: Cohort 1: Number of participants with abnormal ECG findings

Time: Up to Day 14

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-24) of gepotidacin

Time: Up to 24 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-48) of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: T1/2 of a gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Vz/F of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: CL/F of gepotidacin

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Ae total of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-24) of gepotidacin in urine

Time: Up to 24 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: AUC(0-48) of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: CLr of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: Ae(t1-t2) of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 2: fe% of gepotidacin in urine

Time: Up to 48 hours post dose in each period

Description: AEs will be collected.

Measure: Cohort 2: Number of participants with non-SAEs

Time: Up to Day 20

Description: SAEs will be collected.

Measure: Cohort 2: Number of participants with SAEs

Time: Up to Day 20

Description: Blood samples will be collected for the assessment of hematology parameters.

Measure: Cohort 2: Number of participants with abnormal hematology parameters

Time: Up to Day 20

Description: Blood samples will be collected for the assessment of chemistry parameters.

Measure: Cohort 2: Number of participants with abnormal clinical chemistry parameters

Time: Up to Day 20

Description: Urine samples will be collected for the assessment of urinalysis parameters.

Measure: Cohort 2: Number of participants with abnormal urinalysis findings

Time: Up to Day 20

Description: Number of participants with abnormal vital signs will be assessed.

Measure: Cohort 2: Number of participants with abnormal vital signs

Time: Up to Day 20

Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.

Measure: Cohort 2: Number of participants with abnormal ECG findings

Time: Up to Day 20

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Cmax of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Tmax of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Tlag of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-tau) of gepotidacin first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Cmax of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in each Period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Tmax of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: RoCmax of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of morning dose up to 48 hours post evening dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: RoAUC of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of morning dose up to 48 hours post evening dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-tau) of gepotidacin after the second dose of 3000 mg (evening dose)

Time: From start of evening dose up to 48 hours post evening dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-24) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 24 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-48) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 48 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-t) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Vz/Fof gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: CL/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: T1/2 of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: Trough concentration (Cmin) of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: t1/2 of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: Vz/F of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

Measure: Cohort 3: CL/F of digoxin

Time: Up to 96 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: Cmin of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: t1/2 of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: Vz/F of midazolam

Time: Up to 48 hours post dose in each period

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

Measure: Cohort 3: CL/F of midazolam

Time: Up to 48 hours post dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Ae total of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: Ae(t1-t2) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-tau) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-24) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 24 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: AUC(0-48) of gepotidacin in urine following two 3000 mg doses (urine)

Time: From start of morning dose up to 48 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: fe% of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 48 hours post morning dose in each period

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 3: CLr of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in each period

Description: AEs will be collected.

Measure: Cohort 3: Number of participants with non-SAEs

Time: Up to Day 30

Description: SAEs will be collected.

Measure: Cohort 3: Number of participants with SAEs

Time: Up to Day 30

Description: Blood samples will be collected for the assessment of hematology parameters.

Measure: Cohort 3: Number of participants with abnormal hematology parameters

Time: Up to Day 30

Description: Blood samples will be collected for the assessment of chemistry parameters.

Measure: Cohort 3: Number of participants with abnormal clinical chemistry parameters

Time: Up to Day 30

Description: Urine samples will be collected for the assessment of urinalysis parameters.

Measure: Cohort 3: Number of participants with abnormal urinalysis

Time: Up to Day 30

Description: Number of participants with abnormal vital signs will be assessed.

Measure: Cohort 3: Number of participants with abnormal vital signs

Time: Up to Day 30

Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG findings will be assessed.

Measure: Cohort 3: Number of participants with abnormal ECG findings

Time: Up to Day 30

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: T1/2 of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Vz/F of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: CL/F of gepotidacin after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Tlag of gepotidacin after the first dose of 3000 mg (morning dose)

Time: Up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Vz/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: CL/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: t1/2 of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Ae total of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Ae(t1-t2) of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-tau) of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-24) of gepotidacin in urine after a single 1500 mg dose

Time: Up to 24 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-48) of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: fe% of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: CLr of gepotidacin in urine after a single 1500 mg dose

Time: Up to 48 hours post dose in Period 1 and Period 2

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Ae total of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: Ae(t1-t2) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-tau) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-24) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 24 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: AUC(0-48) of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 48 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: fe% of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

Measure: Cohort 4: CLr of gepotidacin in urine following two 3000 mg doses

Time: From start of morning dose up to 60 hours post morning dose in Period 3

HPO Nodes


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HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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