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

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325; Drug: FDC of Norethindrone and Ethinyl Estradiol; Drug: BMS-791325

• Registration Number: NCT02103569
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

IND Number: 79,599 and 101,943

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

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325	FDC of Daclatasvir, Asunaprevir and BMS-791325	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
Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325	FDC of Norethindrone and Ethinyl Estradiol	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
Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325	BMS-791325	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
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