NCT02365532

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

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 Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Long QT Syndrome

Interventions

Type	Name	Description
DRUG	GS-6615	GS-6615 tablets administered orally
DRUG	Placebo to match GS-6615	Placebo to match GS-6615 tablets administered orally
DRUG	Placebo to match dofetilide	Placebo to match dofetilide capsules administered orally
DRUG	Dofetilide	Dofetilide 500 μg capsules administered orally according to the current prescribing information

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-02-19
• Last updated: 2015-05-20

Locations

1 site across 1 country: United States