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GSK3882347Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D014552 Urinary Tract Infections NIH 0.71

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Double-Blind Randomized, Placebo-Controlled, Single and Repeated Oral Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of GSK3882347 in Healthy Participants

This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, first time in human (FTIH) study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetics (PK) of GSK3882347 in healthy adult men and Woman of Non Childbearing Potential (WONCBP). Part 1 will be the single ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each participant in the SAD cohort will receive a single dose of GSK3882347 or placebo (PBO) in 3:1 ratio and in Part 2 (MAD), participants will be randomized in a 4:1 ratio to receive active treatment and placebo. Part 1 will consist of two cohorts with a maximum of four-period for each cohort, the food effect evaluation will be conducted in last period (Period 4) in only one of the cohorts based on the observed human pharmacokinetics (PK). Part 2 will consist of maximum of four cohorts for each of the MAD dose or placebo.

NCT04488770 Urinary Tract Infections Drug: GSK3882347 Drug: Placebo
MeSH:Urinary Tract Infections

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.

Measure: Part 1: Number of participants with Adverse events (AEs)

Time: Up to Week 15

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.

Measure: Part 2: Number of participants with AEs

Time: Up to Week 4

Description: Treatment related AE is any untoward medical occurrence in a clinical study participant, having causal relation with the use of a study intervention.

Measure: Part 1: Number of participants with treatment related AEs

Time: Up to Week 15

Description: Treatment related AE is any untoward medical occurrence in a clinical study participant, having causal relation with the use of a study intervention.

Measure: Part 2: Number of participants with treatment related AEs

Time: Up to Week 4

Description: Number of participants with clinically significant abnormal findings in hematology parameters will be assessed.

Measure: Part 1: Number of participants with clinically significant abnormal findings in hematology parameters

Time: Up to Week 15

Description: Number of participants with clinically significant abnormal findings in hematology parameters will be assessed.

Measure: Part 2: Number of participants with clinically significant abnormal findings in hematology parameters

Time: Up to Week 4

Description: Number of participants with clinically significant abnormal findings in clinical chemistry parameters will be assessed.

Measure: Part 1: Number of participants with clinically significant abnormal findings in clinical chemistry parameters

Time: Up to Week 15

Description: Number of participants with clinically significant abnormal findings in clinical chemistry parameters will be assessed.

Measure: Part 2: Number of participants with clinically significant abnormal findings in clinical chemistry parameters

Time: Up to Week 4

Description: Number of participants with abnormal urinalysis parameters will be assessed.

Measure: Part 1: Number of participants with abnormal urinalysis results

Time: Up to Week 15

Description: Number of participants with abnormal urinalysis parameters will be assessed.

Measure: Part 2: Number of participants with abnormal urinalysis results

Time: Up to Week 4

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

Measure: Part 1: Number of participants with clinically significant abnormal vital signs

Time: Up to Week 15

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

Measure: Part 2: Number of participants with clinically significant abnormal vital signs

Time: Up to Week 4

Description: Number of participants with abnormal ECG parameters will be assessed.

Measure: Part 1: Number of participants with clinically significant abnormal Electrocardiogram (ECG) findings

Time: Up to Week 15

Description: Number of participants with abnormal ECG parameters will be assessed.

Measure: Part 2: Number of participants with clinically significant abnormal ECG findings

Time: Up to Week 4

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Area under the concentration-time curve from time zero to 24 hours after dosing (AUC [0-24]) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: AUC extrapolated from time zero to infinity (AUC[0-inf]) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Maximum plasma concentration (Cmax) of GSK3882347 single dose (nanograms per milliliter)

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Plasma concentrations at 24 hours after dosing (C24h) of GSK3882347 single dose

Time: Day 1: 24 hour post dose in each treatment period

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Time to Cmax (Tmax) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Lag time for absorption (tlag) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Terminal elimination half-life (T1/2) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: AUC over the dosing interval tau (AUC[0-tau]) of GSK3882347 repeat dose

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: Cmax of GSK3882347 repeat dose

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: Tmax of GSK3882347 repeat dose

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: Plasma concentrations over the dosing interval (Ctau) of GSK3882347 repeat dose

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]

Description: Urine samples will be collected at indicated time points for the assessment of urinary concentration.

Measure: Part 1: Urine concentration at 22-24 hours collection time point

Time: Day 1 [22-24 hours post dose in each treatment period]

Description: Urine samples will be collected at indicated time points for the assessment of urinary concentration.

Measure: Part 2: Urine concentration at 22-24 hours collection time point

Time: Days 1 and 7 [22-24 hours post dose]

Description: Urine samples will be collected at indicated time intervals for the assessment of amount excreted in urine of unchanged GSK3882347.

Measure: Part 1: Amount excreted in urine (Ae) of unchanged GSK3882347

Time: Day 1 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48- 60, 60-72, 72-84, and 84-96 hour post dose in each treatment period]

Description: Urine samples will be collected at indicated time intervals for the assessment of amount excreted in urine of unchanged GSK3882347.

Measure: Part 2: Amount excreted in urine (Ae) of unchanged GSK3882347

Time: Days 1 and 7 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hour post dose]

Description: Urine samples will be collected at indicated time points for the assessment of fraction of the dose excreted in urine GSK3882347.

Measure: Part 1 Fraction of the dose excreted in urine (fe) following single dose GSK3882347

Time: Day 1 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48- 60, 60-72, 72-84, and 84-96 hours post dose in each treatment period]

Description: Urine samples will be collected at indicated time points for the assessment of fraction of the dose excreted in urine GSK3882347.

Measure: Part 2: Fraction of the dose excreted in urine (fe) following single dose GSK3882347

Time: Days 1 and 7 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 post dose in each of the 4 cohorts]

Description: Urine samples will be collected at indicated time points for the assessment renal clearance of GSK3882347.

Measure: Part 1: Renal clearance (CLr) following single dose GSK3882347

Time: Day 1 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48- 60, 60-72, 72-84, and 84-96 hours post dose]

Description: Urine samples will be collected at indicated time points for the assessment renal clearance of GSK3882347.

Measure: Part 2: Renal clearance (CLr) following single dose GSK3882347

Time: Days 1 and 7 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 post dose]

Secondary Outcomes

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: AUC from time zero to 12 hours after dosing (AUC[0-12]) following single dose of GSK3882347

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hour post dose in each treatment period]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Plasma concentrations at 12 hours (C12) following single dose of GSK3882347

Time: Day 1 [12 hour post dose in each treatment period]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Apparent oral clearance (CL/F) following single dose of GSK3882347

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Apparent volume of distribution after non-intravenous administration (Vd/F) following single dose of GSK3882347

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Mean residence time (MRT) following single dose of GSK3882347

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: AUC[0-12] following repeat dose of GSK3882347

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, and 12, hour post dose]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: C12 following repeat dose of GSK3882347

Time: Days 1 and Day 7 [12 hour post dose]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: Observed accumulation ratio (Ro) using AUC(0-tau) following repeat dose of GSK3882347

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24, hour post dose]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347. The time invariance will be estimated by calculating the ratio of AUC(0-tau) on Day 7 to AUC(0-inf) on Day 1.

Measure: Part 2: Time invariance of GSK3882347 using AUC(0-tau) (repeat dose) and AUC(0-inf) (single dose)

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24, hour post dose]

Description: Blood samples will be collected at indicated time points to confirm achievement of steady-state of GSK3882347 after repeated dosings.

Measure: Part 2: Plasma concentrations over the dosing interval (Ctau) of GSK3882347 after repeat doses

Time: Pre-dose on Days 3 through 7

No related HPO nodes (Using clinical trials)