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Report for D007896: Leishmaniasis NIH
(Synonyms: Leishma, Leishmani, Leishmaniasis)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1156 | GSK3494245 Wiki | 1.00 |
| drug2122 | Placebo Wiki | 0.05 |
Correlated MeSH Terms (0)
| Name (Synonyms) | Correlation |
|---|
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
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There is one clinical trial.
Clinical Trials
1 A Randomized, Double-blind, Placebo-controlled, First Time in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single (in Both Fed and Fasted States) Doses of GSK3494245 in Healthy Participants
This is a Phase 1, double-blind, randomized, placebo-controlled, first time in human (FTIH) study to assess the safety, tolerability and PK of a single dose of GSK3494245. The study will consist of 3 cohorts, conducted in a sequential manner. Cohorts 1 and 2 will consist of a single ascending dose (SAD), crossover design where each participant will receive a maximum of 3 ascending oral doses of GSK3494245 and 1 placebo dose under fasted conditions. At each dose level, GSK3494245 and placebo will be administered in a 3:1 ratio, within each period, according to the randomization schedule in a blinded manner. Cohort 3 will comprise of a 2-way crossover which includes 1 dosing regimen under fasted then fed conditions and 1 regimen under fed then fasted conditions in a 1:1 ratio. The fed conditions will investigate the effect of safety, tolerability and PK of a single dose of GSK3494245 following food administration.
NCT04504435 Leishmaniasis Drug: GSK3494245 Drug: Placebo MeSH:Leishmaniasis
Primary Outcomes
Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose: results in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Measure: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Time: Up to 14 days post last dose in each treatment periodDescription: Treatment emergent AE and SAE are any untoward medical occurrences in a clinical study participant, having causal relation with the use of a study intervention.
Measure: Number of participants with treatment emergent AEs and SAEs Time: Up to 14 days post last dose in each treatment periodDescription: Blood samples will be collected for the assessment of hematology parameters.
Measure: Number of participants with clinically significant abnormal findings in hematology parameters Time: Up to 14 days post last dose in each treatment periodDescription: Blood samples will be collected for the assessment of chemistry parameters
Measure: Number of participants with clinically significant abnormal findings in clinical chemistry parameters Time: Up to 14 days post last dose in each treatment periodDescription: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Number of participants with urinalysis findings Time: Up to 14 days post last dose in each treatment periodDescription: Number of participants with abnormal vital signs will be assessed.
Measure: Number of participants with clinically significant abnormal findings in vital signs Time: Up to 14 days post last dose in each treatment periodDescription: Triplicate 12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS interval, QT interval, Corrected QT (QTc) interval.
Measure: Number of participants with clinically significant abnormal findings in Electrocardiogram (ECG) Parameters Time: Up to 14 days post last dose in each treatment periodDescription: Telemetry is the continuous monitoring of a participants heart rate and rhythm from a remote location. Continuous cardiac telemetry will start in a supine position after at least 5 minutes rest.
Measure: Number of participants with abnormal cardiac telemetry findings Time: Up to 24 hours post dose on Day 1Secondary Outcomes
Description: Blood samples will be collected at the indicated time points to evaluate AUC (0-t) of GSK3494245 under fasting condition.
Measure: Area under the plasma drug concentration (AUC) versus time curve (AUC[0-t]) of GSK3494245 following single dose administration under fasting condition Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 minutes [min], 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate AUC (0-t) of GSK3494245 under fed condition.
Measure: AUC (0-t) of GSK3494245 following single dose administration under fed condition Time: Cohort 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate AUC (0-inf) of GSK3494245 under fasting condition.
Measure: AUC-time curve from time zero to extrapolated to infinity (AUC[0-inf]) of GSK3494245 following single dose administration under fasting condition Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate AUC(0-inf) of GSK3494245 under fed condition.
Measure: AUC (0-inf) of GSK3494245 following single dose administration under fed condition Time: Cohort 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate Cmax of GSK3494245 under fasting condition.
Measure: Maximum observed plasma drug concentration (Cmax) of GSK3494245 following single dose administration under fasting condition Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate Cmax of GSK3494245 under fed condition.
Measure: Cmax of GSK3494245 following single dose administration under fed condition Time: Cohort 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate Tmax of GSK3494245 under fasting condition.
Measure: Time to maximum observed plasma drug concentration (Tmax) of GSK3494245 following single dose administration under fasting condition Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate Tmax of GSK3494245 under fed condition.
Measure: Tmax of GSK3494245 following single dose administration under fed condition Time: Cohort 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate t1/2 of GSK3494245.
Measure: Apparent terminal half-life (t1/2) of GSK3494245 following single dose administration under fasting condition Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate t1/2 of GSK3494245.
Measure: t1/2 of GSK3494245 following single dose administration under fed condition Time: Cohort 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Urine samples will be collected at the indicated time points to evaluate Ae0-24h of GSK3494245.
Measure: Amount of GSK3494245 excreted in urine over 24 hours (Ae0-24h) following single dose administration Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Urine samples will be collected at the indicated time points to evaluate fe% of GSK3494245
Measure: Fraction of dose excreted in urine over 24 hours (fe%) of GSK3494245 following single dose administration Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Urine samples will be collected at the indicated time points to evaluate CLr of GSK3494245.
Measure: Renal Clearance (CLr) of GSK3494245 following single dose administration Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate AUC(0-inf) of GSK3494245.
Measure: Dose-proportionality assessment using AUC(0-inf) following single dose of GSK3494245 Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate Cmax of GSK3494245.
Measure: Dose-proportionality assessment using Cmax following single dose of GSK3494245 Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)