Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AI438-071 | Other Identifier | Bristol-Myers Squibb |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Single BMS-663068 tablet under fasted conditions |
|
| Treatment B | Experimental | Single BMS-663068 tablet with a high fat meal |
|
| Treatment C | Experimental | Single BMS-663068 tablet after a single famotidine tablet under fasted conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-663068 | Drug | BMS-663068 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Days 1-12 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF) | Days 1-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation | Adverse events (both serious and nonserious) will be listed and tabulated by system organ class, preferred term, and treatment. | Days 1-12; for SAEs up to 30 days post discontinuation of dosing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C576364 | fostemsavir |
Not provided
Not provided
Not provided