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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: FDC of Norethindrone and Ethinyl Estradiol; Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325; Drug: BMS-791325

Study type: Interventional

Funder types: Industry

Identifiers

NCT02103569

AI443-016

Details and patient eligibility

About

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.

Full description

IND Number: 79,599 and 101,943

Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects

Enrollment: 20 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy females within age of 18-40 years
• Must be a Women of Childbearing potential
• Must be on a stable regimen of oral contraceptive therapy for at least 3 consecutive months prior to study start

Exclusion Criteria:

• Subjects must not have any significant acute or chronic medical illnesses or conditions precluding safe use of oral contraceptives
• Prior exposure to DCV, ASV or BMS-791325 within 30 days of dosing on study day 1
• Smoking within 6 months of study start

Trial design

20 participants in 1 patient group

Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325

Experimental group

Description:

Cycle 1- Low dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days Cycle 2- High dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days and High dose FDC of Norethindrone and Ethinyl Estradiol + FDC of Daclatasvir, Asunaprevir and BMS-791325 + BMS-791325 tablets orally on specified days

Treatment:

Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325

Drug: BMS-791325

Drug: FDC of Norethindrone and Ethinyl Estradiol