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

August 13, 2014 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

IND Number: 79,599 and 101,943

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional 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

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: BMS-791325
Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325
Drug: FDC of Norethindrone and Ethinyl Estradiol
Other Names:
  • Loestrin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 21 to Day 49
Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone
Time Frame: Day 21 to Day 49
Day 21 to Day 49

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 1 to Day 50
Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone
Time Frame: Day 1 to Day 50
Day 1 to Day 50
Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone
Time Frame: Day 1 to Day 50
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
Day 1 to Day 50
Safety measured by abnormalities in vital sign measurements
Time Frame: Day 1 to Day 50
Day 1 to Day 50
Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations
Time Frame: Day 1 to Day 50
Day 1 to Day 50
Safety measured by marked abnormalities in clinical laboratory test results
Time Frame: Day 1 to Day 50
Day 1 to Day 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI443-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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