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| ID | Type | Description | Link |
|---|---|---|---|
| AI438-054 | Other Identifier | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of BMS-663068.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | BMS-663068 1 × 600 mg extended-release (ER) tablet formulation |
|
| Part 1: Prototype 1 | Experimental | BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1) |
|
| Part 1: Prototype 2 | Experimental | BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2) |
|
| Part 1: Prototype 3 | Experimental | BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3) |
|
| Part 1: Prototype 4 | Experimental | BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4) |
|
| Part 1: Prototype 5 | Experimental | BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-663068 | Drug | BMS-663068 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of BMS-626529 | Day 1 to Day 4 of each period | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529 | Day 1 to Day 4 of each period | |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529 | Day 1 to Day 4 of each period |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of BMS-663068 will be measured by incidence of Adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation;, and results of clinical laboratory tests, vital signs, 12-lead ECGs, and Physical examination (PE) | Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing | |
| Tolerability of BMS-663068 will be measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of clinical laboratory tests, vital signs and 12-lead ECGs |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Any significant acute or chronic medical illness
Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat:
i) PR ≥ 210 msec ii) QRS ≥ 120 msec iii) QT ≥ 500 msec and iv) QTcF ≥ 450 msec
Exposure to any investigational drug or placebo within 12 weeks of study drug administration
Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Nottingham | NG11 6JS | United Kingdom |
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| Part 2 | Experimental | BMS-663068 1 × 600 mg ER tablet formulation |
|
| Part 2: Prototype 1 | Experimental | BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1) |
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| Part 2: Prototype 2 | Experimental | BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2) |
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| Part 2: Prototype 3 | Experimental | BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3) |
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| Part 2: Prototype 4 | Experimental | BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4) |
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| Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing |
| 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 |
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| ID | Term |
|---|---|
| C576364 | fostemsavir |
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