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TERMINATED
NCT04504435
PHASE1

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study is the first to test GSK3494245 in humans, to evaluate its safety, tolerability, and pharmacokinetics (PK) after a single dose. It involves 3 groups of participants and has a crossover design where each participant received a maximum of 3 ascending oral doses of GSK3494245 and 1 placebo dose under fasted conditions. The first 2 Cohorts received up to 3 increasing doses of the drug and 1 dose of a placebo under fasted conditions, within each period, according to the randomization schedule, in a blinded manner. Cohort 3 is comprised 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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2020-09-29

Completion Date

2024-01-14

Last Updated

2026-05-01

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

GSK3494245

Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.

DRUG

Placebo

Matching placebo capsules were provided

Locations (1)

GSK Investigational Site

Cambridge, United Kingdom