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To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Ortho Tri-Cyclen® | Active Comparator | 1 to 28 days |
|
| Arm B - Ortho Tri-Cyclen® | Active Comparator | 29 to 56 days |
|
| Arm C - Ortho Tri-Cyclen® + BMS-650032 | Active Comparator | Ortho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ortho Tri-Cyclen® | Drug | Tablets, Oral, 1 Tablet, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU) | 24 hours of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered | Safety will be assessed through day 78 | |
| To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination | PK assessments will be done on Day 49, 50, 77 and 78 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pra International | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C109079 | norgestimate, ethinyl estradiol drug combination |
| C571889 | asunaprevir |
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| BMS-650032 | Drug | Tablets, Oral, 600 mg, BID |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |