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 Squibb20 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

FDC of Daclatasvir, Asunaprevir and BMS-791325DRUG

FDC of Norethindrone and Ethinyl EstradiolDRUG

BMS-791325DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Day 21 to Day 49

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

Time frame: Day 21 to Day 49

Secondary Outcomes

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

Time frame: Day 1 to Day 50

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

Time frame: Day 1 to Day 50

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

Time frame: Day 1 to Day 50

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

Time frame: Day 1 to Day 50

Safety measured by abnormalities in vital sign measurements

Time frame: Day 1 to Day 50

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

Time frame: Day 1 to Day 50

Safety measured by marked abnormalities in clinical laboratory test results

Time frame: Day 1 to Day 50

Data from ClinicalTrials.gov

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