Clinical Trial: Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Hea

Brief Summary: This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with dofetilide-induced QTc prolongation.

Detailed Summary:
Sponsor: Gilead Sciences

Current Primary Outcome:

  • Change in daytime QT interval corrected for heart rate using the Fridericia formula (QTcF) [ Time Frame: Up to 6 days ]
  • Pharmacokinetic (PK) profiles of GS-6615 and dofetilide [ Time Frame: Predose and postdose on Days -2 through Day 4 ]
    This endpoint will measure the plasma PK profiles of GS-6615 and dofetilide. PK parameters that will be measured include Cmax, Tmax, AUC_0-24, and AUC_0-tlast.


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of adverse events, clinical laboratory test results, vital sign measurements, and electrocardiogram (ECG) data [ Time Frame: Up to 6 days ]

This endpoint will measure the safety and tolerability profile of GS-6615.


Original Secondary Outcome: Same as current

Information By: Gilead Sciences

Dates:
Date Received: February 13, 2015
Date Started: February 2015
Date Completion:
Last Updated: May 19, 2015
Last Verified: May 2015