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

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2014

Detailed Description

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

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Arm 1: FDC of NE/EE + DCV 3DAA FDC + 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol Myers Squibb, Study Director, Bristol-Myers Squibb

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