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| ID | Type | Description | Link |
|---|---|---|---|
| AI468-041 | Other Identifier | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: NGMN/EE + BMS-955176 | Experimental | Cycle 1- Active Ortho Cyclen QD on Days 1 to 21. Inert Ortho Cyclen tablets on Days 22 to 28 Cycle 2- Active Ortho Cyclen QD alone on Days 29 to 39 (11 days), followed by concomitant administration of active Ortho Cyclen QD + BMS-955176 80 mg QD on Days 40 to 49 (10 days) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-955176 | Drug |
| ||
| Ortho Cyclen |
| Measure | Description | Time Frame |
|---|---|---|
| Serial blood samples for plasma Ethinyl Estradiol and Norelgestromin determination | Before dosing (0 hour) through 24 hours after administration on Days 21 and 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum progesterone measurements | Day 14, 21, 35, and 42 | |
| Trough blood samples collected for BMS-955716 | Days 48, 49, 50 | |
| Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. |
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Inclusion Criteria:
Signed Written Informed Consent a) The signed informed consent form
Target population
Age and Reproductive Status
Exclusion Criteria:
Medical History and Concurrent Diseases
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| Name | Affiliation | Role |
|---|---|---|
| Viiv Clinical Trials | ViiV Healthcare | Study Director |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000627567 | BMS-955176 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
| Two to three months |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |