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NCT04425902 · ClinicalTrials.gov registry record · Phase 1

Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults

A Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT04425902 is a Phase 1 study of HIV Infections that has completed, run by ViiV Healthcare. The registered enrollment target is 20 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04425902, a Phase 1 study of HIV Infections, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

HIV Infections

Interventions

  • DRUG GSK3640254 200 mg
  • DRUG Caffeine 200 mg
  • DRUG Metoprolol 100 mg
  • DRUG Montelukast 10 mg
  • DRUG Flurbiprofen 100 mg

Study Locations (1)

Nevada

  • GSK Investigational Site - Las Vegas

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-12-16
Est. Completion 2021-03-10
Phase Phase 1

Sponsor

ViiV Healthcare

182 total trials

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What the Registry Record Tells You About NCT04425902

The ClinicalTrials.gov registry entry for NCT04425902 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which GSK3640254 200 mg is the first listed.

NCT04425902 reports 1 study location spanning 1 distinct geographic area - top geographies include Nevada.

Frequently Asked Questions

What is clinical trial NCT04425902 about?

NCT04425902 is a clinical study titled "Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults". 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 understan...

What is the current status of trial NCT04425902?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-12-16. Estimated completion is 2021-03-10.

What conditions does trial NCT04425902 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT04425902?

The interventions under investigation include: GSK3640254 200 mg (DRUG), Caffeine 200 mg (DRUG), Metoprolol 100 mg (DRUG), Montelukast 10 mg (DRUG), Flurbiprofen 100 mg (DRUG).

Who is sponsoring clinical trial NCT04425902?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04425902 being conducted?

This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.