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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: FDC of Daclatasvir, Asunaprevir and BMS-791325 (Drug)
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
Intervention: FDC of Norethindrone and Ethinyl Estradiol (Drug)
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
Intervention: BMS-791325 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- 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)