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| ID | Type | Description | Link |
|---|---|---|---|
| AI438-053 | Other Identifier | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
A single oral dose study in subjects with hepatic impairment and healthy control subjects. Subjects will stay at the clinical facility where interval blood samplings will be obtained and examined for drug effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Active Comparator | Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1. |
|
| Hepatic Impaired Subjects - Mild Rating | Active Comparator | Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. |
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| Hepatic Impaired Subjects - Moderate Rating | Active Comparator | Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. |
|
| Hepatic Impaired Subjects - Severe Rating | Active Comparator | Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-663068 | Drug | BMS-663068 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite). | 5 days | |
| The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (INF) of BMS-626529 (metabolite). | 5 days | |
| The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (0-T) of BMS-626529 (metabolite). | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability of a 600-mg single dose of BMS-663068 in subjects with hepatic impairment and in healthy subjects through analysis of adverse events. | Adverse events will be arranged by system organ class, preferred term and hepatic function group. In addition, electrocardiogram readings will be summarized by time point relative to hepatic function group, and investigator-identified abnormalities, if present, will be listed. |
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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 | Hamilton | New Jersey | 08690 | United States |
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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 |
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| 5 days |
| The relationship between the Child-Pugh classification (including its components) as well as liver function tests and BMS-626529 profile PK parameters. | 5 days |
| 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 |