CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
GSK3640254 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04563845
NCT04563845Phase 1Completed

A Study to Evaluate the Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction as Assessed by 12-Lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin in Healthy Adult Participants

ViiV Healthcare·interventional·Posted Sep 25, 2020·Updated Dec 6, 2023

In Brief

A Phase 1 clinical trial evaluating GSK3640254, Placebo, and 1 other intervention for HIV Infections. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. The study has 2 parts: Part 1 will determine the supratherapeutic dose for Part 2, which will be the main corrected QT interval (QTc) study. Part 1 will evaluate once daily (QD) dosing of GSK3640254 or placebo and Part 2 will investigate the safety, tolerability and Pharmacokinetics (PK) of GSK3640254 doses on cardiac conduction as compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. Moxifloxacin will be included as a positive control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedSep 25, 2020
Enrollment StartNov 9, 2020
Primary CompletionOct 30, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.8 years ago

Interventions

GSK3640254drug

GSK3640254 will be administered.

Placebodrug

Placebo will be administered.

Moxifloxacindrug

Moxifloxacin will be administered.