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| ID | Type | Description | Link |
|---|---|---|---|
| AI438-068 | Other Identifier | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The study is being conducted to assess the effect of multiple doses of BMS-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and norbuprenorphine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (BMS-663068+methadone) | Experimental | Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone |
|
| Part 2 (BMS-663068+buprenorphine and norbuprene) | Experimental | Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-663068 | Drug | BMS-663068 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2) | Days 1 to 10 | |
| AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2) | Days 1 to 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation. | For AEs, Days 1 to 10; for SAEs, Screening, Days 1 to 10 and 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 | Orlando | Florida | 32809 | 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 |
| D008691 | Methadone |
| D002047 | Buprenorphine |
| C043585 | norbuprenorphine |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Methadone | Drug | Methadone |
|
| Buprenorphine and Norbuprenorphine | Drug | Buprenorphine and Norbuprenorphine |
|
| Overland Park |
| Kansas |
| 66211 |
| 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 |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |