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

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325
* Drug: FDC of Norethindrone and Ethinyl Estradiol
* Drug: BMS-791325


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325<br>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 | Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325<br> <br> Drug: FDC of Norethindrone and Ethinyl Estradiol<br> <br> * Other names: Loestrin®;Drug: BMS-791325<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone |  | Day 21 to Day 49 | 
| Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone |  | Day 21 to Day 49 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone |  | Day 1 to Day 50 | 
| Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone |  | Day 1 to Day 50 | 
| Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone |  | Day 1 to Day 50 | 
| Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation |  | Day 1 to Day 50 | 
| Safety measured by abnormalities in vital sign measurements |  | Day 1 to Day 50 | 
| Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations |  | Day 1 to Day 50 | 
| Safety measured by marked abnormalities in clinical laboratory test results |  | Day 1 to Day 50 |