CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

[14C]-GSK3640254 intravenous infusionWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug3160 [14C]-GSK3640254 powder Wiki 1.00
drug1159 GSK3640254 Oral tablet Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D015658 HIV Infections NIH 0.32

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Two-period Study in Healthy Male Participants to Determine the Pharmacokinetics, Balance/Excretion, and Metabolism of [14C]-GSK3640254 Following a Single Intravenous Radiolabeled Microtracer Dose (Concomitant With a Non-radiolabeled Oral Dose) and a Single Oral Radiolabeled Dose

This is an open-label, single-center, single group, non-randomized, two-period, single sequence, mass balance study which will enroll 6 healthy male participants. This study will assess the pharmacokinetics, balance/excretion, and metabolism of GSK3640254 in humans using [14C]-radiolabeled drug substance administered as an intravenous (IV) infusion and via the oral route. The study will also provide an assessment of GSK3640254 absorption, metabolism and excretion following administration of a [14C]-radiolabeled oral suspension. Each participant will be involved in the study for up to 10 weeks which will include a screening period, two treatment periods (treatment Periods 1 and 2) separated by a washout of at least 13 days between oral doses, and a follow-up visit 7-14 days after the last assessment in treatment Period 2.

NCT04507321 HIV Infections Drug: GSK3640254 Oral tablet Drug: [14C]-GSK3640254 intravenous infusion Drug: [14C]-GSK3640254 powder
MeSH:HIV Infections

Primary Outcomes

Description: Blood samples will be collected at the indicated time points to evaluate [14C]-GSK3640254 in plasma.

Measure: Treatment period 1: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) in plasma following administration of IV dose of 14 Carbon [14C]-GSK3640254

Time: Day 1 (Pre-dose, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate GSK3640254 in plasma.

Measure: Treatment period 1: AUC(0-inf) in plasma following administration of oral dose of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in plasma.

Measure: Treatment period 1: AUC(0-inf) of total radioactivity in plasma following administration of IV dose of [14C]-GSK3640254

Time: Screening, Day-1, Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate GSK3640254 in plasma.

Measure: Treatment period 2: AUC(0-inf) in plasma following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in plasma.

Measure: Treatment period 2: AUC(0-inf) of total radioactivity in plasma following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate [14C]-GSK3640254 in plasma.

Measure: Treatment period 1: AUC from time zero (pre-dose) to last time of quantifiable concentration within a participant across all treatments (AUC[0-t]) in plasma following administration of IV dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate GSK3640254 in plasma.

Measure: Treatment period 1: AUC (0-t) in plasma following administration of oral dose of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in plasma.

Measure: Treatment period 1: AUC(0-t) of total radioactivity in plasma following administration of IV dose of [14C]-GSK3640254

Time: Screening, Day-1, Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate GSK3640254 in plasma.

Measure: Treatment period 2: AUC (0-t) in plasma following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in plasma.

Measure: Treatment period 2: AUC(0-t) of total radioactivity in plasma following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate [14C]-GSK3640254 in plasma.

Measure: Treatment period 1: Maximum observed concentration (Cmax) in plasma following administration of IV dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate GSK3640254 in plasma.

Measure: Treatment period 1:Cmax in plasma following administration of oral dose of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in plasma.

Measure: Treatment period 1: Cmax of total radioactivity in plasma following administration of IV dose of [14C]-GSK3640254

Time: Screening, Day-1, Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate GSK3640254 in plasma.

Measure: Treatment period 2: Cmax in plasma following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in plasma.

Measure: Treatment period 2: Cmax of total radioactivity in plasma following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in blood.

Measure: Treatment period 2: Cmax of total radioactivity in blood following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (2, 4, 6, 8, 10 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate [14C]-GSK3640254 in plasma.

Measure: Treatment period 1:Time of occurrence of Cmax (Tmax) in plasma following administration of IV dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate GSK3640254 in plasma.

Measure: Treatment period 1:Tmax in plasma following administration of oral dose of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in plasma.

Measure: Treatment period 1: Tmax of total radioactivity in plasma following administration of IV dose of [14C]-GSK3640254

Time: Screening, Day-1, Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate GSK3640254 in plasma.

Measure: Treatment period 2: Tmax in plasma following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in plasma.

Measure: Treatment period 2: Tmax of total radioactivity in plasma following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in blood.

Measure: Treatment period 2: Tmax of total radioactivity in blood following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (2, 4, 6, 8, 10 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate [14C]-GSK3640254 in plasma.

Measure: Treatment period 1:Terminal phase half-life (T1/2) in plasma following administration of IV dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate GSK3640254 in plasma.

Measure: Treatment period 1: T1/2 in plasma following administration of oral dose of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in plasma.

Measure: Treatment period 1: T1/2 of total radioactivity in plasma following administration of IV dose of [14C]-GSK3640254

Time: Screening, Day-1, Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate GSK3640254 in plasma.

Measure: Treatment period 2: T1/2 in plasma following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity in plasma.

Measure: Treatment period 2: T1/2 of total radioactivity in plasma following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of [14C]-GSK3640254.

Measure: Treatment period 1: Volume of distribution at steady state (Vss) following administration of IV dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of [14C]-GSK3640254.

Measure: Treatment period 1: Total systemic clearance (CL) following administration of IV dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Urine samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

Measure: Treatment period 1: Renal clearance (CLr) following administration of IV dose of GSK3640254

Time: Day 1 (Pre-dose), 0-24 Hours, 24-48 Hours, 48-72 Hours, 72-96 Hours, 96-120 Hours, 120-144 Hours, 144-168 Hours

Description: Urine samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

Measure: Treatment period 2: CLr following administration of oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose), 0-24 Hours, 24-48 Hours, 48-72 Hours, 72-96 Hours, 96-120 Hours, 120-144 Hours, 144-168 Hours

Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

Measure: Treatment period 1: Oral Clearance (CL/F) following oral dose of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

Measure: Treatment period 2: CL/F following oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

Measure: Treatment period 1: Apparent volume of distribution (Vz/F) following oral dose of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

Measure: Treatment period 2: Vz/F following oral dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

Measure: Treatment period 1: Absolute oral bioavailability (F) of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

Measure: Treatment period 1: Percentage of drug escaping first pass hepatic clearance (Fh) following administration of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8,9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

Measure: Treatment period 1: Percentage of drug absorbed (Fa) following administration of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

Measure: Treatment period 1: Percentage of drug escaping gut metabolism (Fg) following administration of GSK3640254

Time: Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)

Description: Urine samples will be collected at the indicated time points to determine total radioactivity in urine.

Measure: Treatment period 1: Percentage of total radioactive dose in urine following administration of IV dose of [14C]-GSK3640254

Time: Day 1 (Pre-dose), 0-24 Hours, 24-48 Hours, 48-72 Hours 72 - 96 Hours, 96-120 Hours, 120-144 Hours, 144-168 Hours

Description: Urine samples will be collected at the indicated time points to determine total radioactivity in urine.

Measure: Treatment period 2: Percentage of the total radioactive dose in urine following administration of oral dose of [14C]-GSK3640254

Time: 0-24 Hours, 24-48 Hours, 48-72 Hours, 72-96 Hours, 96-120 Hours, 120-144 Hours, 144-168 Hours

Description: Fecal samples will be collected at the indicated time points to determine total radioactivity in feces.

Measure: Treatment period 1: Percentage of total radioactive dose in feces following administration of IV dose of [14C]-GSK3640254

Time: 0-24 Hours, 24-48 Hours, 48- 72 Hours, 72-96 Hours, 96-120 Hours, 120-144 Hours, 144-168 Hours.

Description: Fecal samples will be collected at the indicated time points to determine total radioactivity in feces.

Measure: Treatment period 2: Percentage of total radioactive dose in feces following administration of oral dose of [14C]-GSK3640254

Time: 0-24 Hours, 24-48 Hours, 48-72 Hours, 72-96 Hours, 96-120 Hours, 120-144 Hours, 144-168 Hours.

Secondary Outcomes

Description: AEs and SAEs will be collected.

Measure: Number of participants With Adverse Events (AEs) and Serious AEs (SAEs)

Time: Up to 50 days

Description: Blood samples and urine samples will be collected for assessment of hematology, clinical chemistry and urine parameters.

Measure: Number of participants with abnormal hematology, clinical chemistry and urinalysis parameters

Time: Day -1, Day 2 (36 hours), Day 5 , Day 8 and up to 50 days

Description: Single12-lead ECG will be recorded with the participant in a supine position. Number of participants with abnormal ECG findings will be assessed.

Measure: Number of participants with abnormal 12-lead electrocardiogram (ECG)

Time: Up to 50 days

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

Measure: Number of participants with abnormal vital signs

Time: Up to 50 days

Description: Blood samples will be collected at the indicated time points to evaluate total radioactivity following administration of oral dose of [14C]-GSK3640254.

Measure: Treatment Period 2: Total radioactivity in blood to plasma following administration of oral dose of [14C]-GSK3640254

Time: 2 Hours, 4 Hours, 6 Hours, 8 Hours, and 10 Hours

No related HPO nodes (Using clinical trials)