NCT04425902

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-12-16
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2020-06-11
• Last updated: 2024-01-05
• Results posted: 2022-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study