drugset / Trial / NCT02103569

Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325

NCT02103569

Phase 1 Completed 20 enrolled Bristol-Myers Squibb
NaSingle-groupOpen-label

Summary

The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent.

Timeline

Start
2014-04
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Asunaprevir Small molecule Oral
Subject Beclabuvir Small molecule 75 mg Oral
Subject Daclatasvir Small molecule Oral
Subject Norethindrone Unknown Oral
Subject ethinyl estradiol Small molecule Oral