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| ID | Type | Description | Link |
|---|---|---|---|
| AI468-052 | Other Identifier | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Single DTG tablet under fed conditions for a specified period |
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| Treatment B | Experimental | Two BMS955176 tablets under fed conditions for a specified period |
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| Treatment C | Experimental | Single DTG tablet and Two BMS955176 tablets under fed conditions for a specified period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir | Drug | Dolutegravir |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) for DTG | Days 1 to 5 and days 15 to 21 | |
| Area under the concentration-time curve in 1 dosing interval AUC (tau) for DTG | Days 1 to 5 and days 15 to 21 | |
| Maximum observed plasma concentration (Cmax) for BMS-955176 | Days 8-21 | |
| Area under the concentration-time curve in 1 dosing interval AUC (tau) for BMS-955176 | Days 8-21 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | The incidence of observed AEs will be tabulated and reviewed for potential significance and clinical importance. | Days 1-21; for SAEs up to 30 days post discontinuation of dosing |
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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 | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| Description FDA Safety Alerts and Recalls | View source |
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| BMS955176 |
| Drug |
BMS955176 |
|
| 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 |
|---|---|
| C562325 | dolutegravir |
| C000627567 | BMS-955176 |
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