NCT02027454

Study to Evaluate the Effect of GSK1265744 on Cardiac Conduction

A Study to Evaluate the Effect of GSK1265744 150mg Administered Orally Every 12h x 3 Doses on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to comply with the Food and Drug Administration (FDA) recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization effects through electrocardiographic evaluation. Therefore, this study will evaluate the effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead continuous digital data in healthy adults. This study will evaluate the effect of three doses of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared to placebo. Moxifloxacin will be used as a positive control in order to validate the sensitivity of the study in detecting QTc change. This study consists of three treatment periods (each separated by 21 day washout period) followed by follow-up visit 10 to 14 days post last dosing. The total duration of study including follow-up visit will be approximately 62 days. Approximately 42 subjects will be enrolled such that 34 subjects complete dosing and critical assessments.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	GSK1265744	White to slightly colored film coated tablet with unit dose strength of 30 mg and dose level of 150mg (5 tablets of 3 mg) administered orally every 12hours for 3 doses.
DRUG	GSK1265744 matching placebo	GSK1265744 matching placebo tablets administered orally every 12hours for 3 doses (5 tablets per dose).
DRUG	Moxifloxacin	Dull red, oblong, convex film coated tablets with unit dose strength of 400 mg administered orally as a single dose.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-01-06
• Last updated: 2014-06-16

Locations

1 site across 1 country: United States