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| ID | Type | Description | Link |
|---|---|---|---|
| AI468-036 | 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 pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single oral dose of [14C] BMS 955176 | Experimental | A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity. |
|
| Nasoduodenal (ND) Tube Cohort | Experimental | A single dose of [14C] BMS 955176 on Day 1 with ND placement 1 hour post dose to facilitate continuous bile collection though 8 hours post dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-955176 | Drug | Single dose of drug on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To asses the PK (AUC, Cmax) of a single oral dose | Serial blood samples for PK parameters determined from plasma concentration versus time | Day 1 through Day 13 (predose to 288 hours) |
| To estimate extent of elimination of a single oral dose (% TRA recovery) | Sample of urinary/fecal/bile will be collected for determining total recovery. | Day 1 through Day 13 (predose to 288 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. | Day 1 through Day 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Viiv Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000627567 | BMS-955176 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |