NCT04507321

Pharmacokinetics and Metabolism of 14 Carbon [14C]-GSK3640254

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: Male
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	GSK3640254 Oral tablet	GSK3640254 will be available as white film-coated round tablets to be administered via oral route with meal in the morning with 240 milliliter (mL) of water at room temperature.
DRUG	[14C]-GSK3640254 intravenous infusion	\[14C\]-GSK3640254 will be available as clear, colorless solution free from visible particulates to be administered via the IV route.
DRUG	[14C]-GSK3640254 powder	\[14C\]-GSK3640254 will be available as white powder to be reconstituted into a suspension with 25 mL of vehicle before dosing so as to administer 85 mg dose with meal in the morning.

Timeline

• Start date: 2020-09-24
• Primary completion: 2020-11-23
• Completion: 2020-11-23
• First posted: 2020-08-11
• Last updated: 2022-01-31
• Results posted: 2022-01-31

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study