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| ID | Type | Description | Link |
|---|---|---|---|
| AI438-080 | Other Identifier | Bristol-Myers Squibb |
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An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529 administered as BMS-663068
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: reference extended-release (ER) 1 tablet at 600mg | Experimental | A single dose of BMS-663068 administered orally as specified |
|
| Treatment B: low-dose ER 4 tablets at 150mg | Experimental | A single dose (4 tablets) of BMS-663068 administered orally as specified |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-663068 (1 tablet at 600 mg) | Drug | BMS-663068 (1 tablet at 600 mg). A single dose of BMS-663068 administered orally as specified. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability of BMS-626529 from low-dose ER tablet formulation of BMS-663068 relative to the reference ER tablet formulation. | Approximately 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of electrocardiogram tests (ECGs), vital signs, physical exams, and clinical laboratory tests. | Approximately 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Dallas | Texas | 75247 | United States |
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| BMS-663068 (4 tablets at 150 mg each tablet) | Drug | BMS-663068 (4 tablets at 150 mg each tablet). A single dose (4 tablets) of BMS-663068 administered orally as specified. |
|
| 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 |
| 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 |
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| ID | Term |
|---|---|
| C576364 | fostemsavir |
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