Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325
NCT ID: NCT02103569
Last Updated: 2014-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2014-04-30
2014-07-31
Brief Summary
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Detailed Description
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Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects
Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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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
FDC of Daclatasvir, Asunaprevir and BMS-791325
FDC of Norethindrone and Ethinyl Estradiol
BMS-791325
Interventions
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FDC of Daclatasvir, Asunaprevir and BMS-791325
FDC of Norethindrone and Ethinyl Estradiol
BMS-791325
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Prior exposure to DCV, ASV or BMS-791325 within 30 days of dosing on study day 1
* Smoking within 6 months of study start
18 Years
40 Years
FEMALE
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Other Identifiers
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AI443-016
Identifier Type: -
Identifier Source: org_study_id
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