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| ID | Type | Description | Link |
|---|---|---|---|
| AI438-019 | Other Identifier | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-663068 with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or norethindrone (NE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Sequence A, B, C, and D | Experimental | Treatment A/Cycle 1: OC containing EE and progestin taken by mouth. Treatment B/Cycle 2: OC containing EE and progestin taken by mouth. Treatment C/Cycle 3: Loestrin 1.5/30 taken by mouth. Treatment D/Cycle 4: Loestrin 1.5/30 (alone) and Loestrin 1.5/30 with BMS-663068 taken by mouth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-663068 | Drug | Investigational product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter Cmax | Pharmacokinetic parameter includes: maximal observed concentration (Cmax) for EE and NE. | From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4 |
| Pharmacokinetic parameter AUC TAU | Pharmacokinetic parameter includes: area under the concentration-time curve in one dosing interval (AUC(TAU)) for EE and NE. | From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Safety as Measured by Adverse Event Monitoring. | Adverse event monitoring | From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) |
| Clinical Safety as Measured by the Collection of Vital Signs. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined exclusion criteria could apply.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Miami | Florida | 33143 | United States | ||
| GSK Investigational Site |
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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 |
|---|---|
| C576364 | fostemsavir |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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| Oral Contraceptive |
| Drug |
Subject's existing combination OC tablet containing EE and progestin |
|
| Loestrin 1.5/30 | Drug | OC containing EE and norethindrone acetate (NEA) |
|
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Vital signs assessments
| From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) |
| Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs). | 12-lead ECGs | From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) |
| Clinical Safety as measured by Physical Examination. | Physical examinations | From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) |
| Clinical Safety as Measured by Clinical Laboratory Evaluations. | clinical chemistry, hematology, and urinalysis. | From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) |
| Pharmacokinetic Parameter | Pharmacokinetic parameter: -time of maximum observed concentration (Tmax) for EE and NE. | From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4 |
| San Antonio |
| Texas |
| 78209 |
| United States |
| 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 |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |