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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02103569

Enrollment

Registered

2014-04-04

Start date

2014-04-30

Completion date

2014-07-31

Last updated

2014-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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

Interventions

DRUGFDC of Daclatasvir, Asunaprevir and BMS-791325

DRUGFDC of Norethindrone and Ethinyl Estradiol

DRUGBMS-791325

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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
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
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 abnormalities in vital sign measurements	Day 1 to Day 50
Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone	Day 1 to Day 50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026