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

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

• HIV Infections

Interventions

DRUG

GSK3640254 200 mg

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

DRUG

Caffeine 200 mg

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

DRUG

Metoprolol 100 mg

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

DRUG

Montelukast 10 mg

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

DRUG

Flurbiprofen 100 mg

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

DRUG

Omeprazole 40 mg

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

DRUG

Midazolam 5 mg (2.5 mL)

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

DRUG

Digoxin 0.25 mg

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

DRUG

Pravastatin 40 mg

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

Sponsors & Collaborators

• ViiV Healthcare

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-16

Primary Completion

2021-03-10

Completion

2021-03-10

FDA Drug

Yes

Countries

• United States

Study Locations