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

NCT04504435 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-05-01

Study results available
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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.

Conditions

  • Leishmaniasis

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2024-01-14
Completion
2024-01-14

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04504435 on ClinicalTrials.gov