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

Condition(s) targeted: Hepatitis C

Intervention: FDC of Daclatasvir, Asunaprevir and BMS-791325 (Drug); FDC of Norethindrone and Ethinyl Estradiol (Drug); BMS-791325 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Official title: Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone

Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone

Secondary outcome:

Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone

Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone

Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone

Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation

Safety measured by abnormalities in vital sign measurements

Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations

Safety measured by marked abnormalities in clinical laboratory test results

Detailed description: IND Number: 79,599 and 101,943 Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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

Starting date: April 2014
Last updated: August 13, 2014