CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
GSK3640254 200 mg +8 moredrug
Likely dose
GSK3640254 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04425902
NCT04425902Phase 1Completed
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Effects of GSK3640254 on the Single-Dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin) in Healthy Subjects

ViiV Healthcare·interventional·Posted Jun 11, 2020·Updated Jan 5, 2024

In Brief

A Phase 1 clinical trial evaluating GSK3640254 200 mg, Caffeine 200 mg, and 7 other interventions for HIV Infections. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This is an open-label, single sequence study that is being conducted to investigate the potential drug-drug interaction (DDI) when GSK3640254 is co-administered with a cocktail of cytochrome P450 (CYP) enzymes and transporter probe substrates in healthy participants. This study will aid in understanding these interactions and resulting changes in exposure (if any) when drugs that are metabolized via these pathways are given in combination with GSK3640254. The study will consist of a Screening period and 3 sequential treatment regimens. Participants will be administered a single dose of probe substrate drugs (caffeine 200 milligram (mg), metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg and pravastatin 40 mg) on Day 1. Participants will then receive GSK3640254 200 mg once daily on Days 11 to 20 followed by co-administration of probe substrate drugs with GSK3640254 on Day 21.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJun 11, 2020
Enrollment StartDec 16, 2020
Primary CompletionMar 10, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.1 years ago

Interventions

GSK3640254 200 mgdrug

GSK3640254 will be available as oral tablets at unit dose strength of 100 mg.

Caffeine 200 mgdrug

Caffeine will be available as oral tablets at unit dose strength of 200 mg.

Metoprolol 100 mgdrug

Metoprolol will be available as oral tablets at unit dose strength of 100 mg.

Montelukast 10 mgdrug

Montelukast will be available as oral tablets at unit dose strength of 10 mg.

Flurbiprofen 100 mgdrug

Flurbiprofen will be available as oral tablets at unit dose strength of 100 mg.

Omeprazole 40 mgdrug

Omeprazole will be available as oral capsules at unit dose strength of 40 mg.

Midazolam 5 mg (2.5 mL)drug

Midazolam will be available as syrup for oral administration at unit dose strength of 2 milligram per milliliter (mg/mL).

Digoxin 0.25 mgdrug

Digoxin will be available as oral tablet at unit dose strength of 0.25 mg.

Pravastatin 40 mgdrug

Pravastatin will be available as oral tablet at unit dose strength of 40 mg.