NCT02175602

Study of Drug Combination on Pharmacokinetics in Healthy Volunteers

Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of Selective Serotonin Reuptake Inhibitors in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.

Conditions

• Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	Escitalopram	10 milligrams administered each morning
DRUG	Sertraline	50 milligrams administered each morning
DRUG	DCV 3DAA FDC	Fixed dose combination (daclatasvir \[DCV\] 30 milligrams, asunaprevir \[ASV\] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily
DRUG	BMS-791325	75 milligrams single-agent film coated oral tablet administered twice daily

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-08-01
• First posted: 2014-06-26
• Last updated: 2015-02-10