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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02103569
Collaborator
(none)
20
Enrollment
1
Arm
3
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325
  • Drug: FDC of Norethindrone and Ethinyl Estradiol
  • Drug: BMS-791325
 Phase 1

Detailed Description

IND Number: 79,599 and 101,943

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

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
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 Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325

Drug: FDC of Norethindrone and Ethinyl Estradiol
Other Names:
  • Loestrin®

    • Drug: BMS-791325

    Outcome Measures

    Primary Outcome Measures

    1. Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone [Day 21 to Day 49]

    2. Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone [Day 21 to Day 49]

    Secondary Outcome Measures

    1. 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]

    2. Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone [Day 1 to Day 50]

    3. Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone [Day 1 to Day 50]

    4. Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation [Day 1 to Day 50]

    5. Safety measured by abnormalities in vital sign measurements [Day 1 to Day 50]

    6. Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations [Day 1 to Day 50]

    7. Safety measured by marked abnormalities in clinical laboratory test results [Day 1 to Day 50]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02103569
    Other Study ID Numbers:
    • AI443-016
    First Posted:
    Apr 4, 2014
    Last Update Posted:
    Aug 15, 2014
    Last Verified:
    Aug 1, 2014
    Additional relevant MeSH terms:
    Hepatitis C
    Ethinyl Estradiol
    Norethindrone
    Norethindrone Acetate
    Estradiol
    Asunaprevir

    Study Results

    No Results Posted as of Aug 15, 2014