NCT04504435

Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants

A Randomized, Double-blind, Placebo-controlled, First Time in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single (in Both Fed and Fasted States) Doses of GSK3494245 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, double-blind, randomized, placebo-controlled, first time in human (FTIH) study to assess the safety, tolerability and PK of a single dose of GSK3494245. The study will consist of 3 cohorts, conducted in a sequential manner. Cohorts 1 and 2 will consist of a single ascending dose (SAD), crossover design where each participant will receive a maximum of 3 ascending oral doses of GSK3494245 and 1 placebo dose under fasted conditions. At each dose level, GSK3494245 and placebo will be administered in a 3:1 ratio, within each period, according to the randomization schedule in a blinded manner. Cohort 3 will comprise of a 2-way crossover which includes 1 dosing regimen under fasted then fed conditions and 1 regimen under fed then fasted conditions in a 1:1 ratio. The fed conditions will investigate the effect of safety, tolerability and PK of a single dose of GSK3494245 following food administration.

Conditions

• Leishmaniasis

Interventions

Type	Name	Description
DRUG	GSK3494245	Capsule of 10-250 mg dose strength will be provided in labelled High Density Polyethylene (HDPE) bottles.
DRUG	Placebo	Matching placebo capsules will be provided

Timeline

• Start date: 2020-09-29
• Primary completion: 2024-01-11
• Completion: 2024-01-11
• First posted: 2020-08-07
• Last updated: 2024-02-22

Locations

1 site across 1 country: United Kingdom