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
Abstract
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.
Conditions: HIV Infections.
Primary outcome: Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) of GSK3640254; Part 1: AUC From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254; Part 1: Maximum Observed Concentration (Cmax) of GSK3640254; Part 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254; Part 1: Time of Maximum Observed Concentration (Tmax) of GSK3640254; Part 1: Plasma Concentration of GSK3640254; Part 1: Plasma Concentration of Major Metabolites of GSK3640254; Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs; Part 1: Absolute Values for Hematology Parameter: Hemoglobin; Part 1: Absolute Values for Hematology Parameter: Hematocrit; Part 1: Absolute…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 50 participants or records.
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