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| ID | Type | Description | Link |
|---|---|---|---|
| AI438-070 | Other Identifier | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Experimental | A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. |
|
| Mild Renal Impairment Subjects | Experimental | A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. |
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| Moderate Renal Impairment Subjects | Experimental | A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. |
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| Severe Renal Impairment Subjects | Experimental | A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. |
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| End Stage Renal Disease Subjects | Experimental | A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral BMS-663068 (pro-drug) | Drug | Oral BMS-663068 (pro-drug), metabolized to active BMS-626529 |
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| Measure | Description | Time Frame |
|---|---|---|
| Effect of Renal Impairment on The Primary Endpoints of Cmax | To assess the effect of varying degrees of renal impairment on the exposure of BMS-626529 after a single oral-dose administration of the pro-drug, BMS-663068, will be evaluated by assessing the primary endpoints of Cmax, for BMS-626529. | Day 1 - Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of ECGs, vital signs, physical examination, and clinical laboratory tests. | To assess the safety and tolerability of BMS-663068 in subjects with normal renal function and subjects with impaired renal functions, will be measured by the following secondary endpoints: Incidence of AEs, Serious Adverse Events (SAEs), and AEs leading to discontinuation, and results of vital signs, ECGs, physical examination, and clinical laboratory tests. |
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Inclusion Criteria (For renal impaired subjects):
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 | Miami | Florida | 33014 | United States |
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| Day 1 - Day 5 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
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| ID | Term |
|---|---|
| C576364 | fostemsavir |
| D011355 | Prodrugs |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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