Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004896-10 | EudraCT Number | ||
| AI468-034 | 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
Not provided
Not provided
The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.
Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C) | Experimental | BMS-955176 single dose by mouth as specified |
|
| Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A) | Experimental | BMS-955176 single dose by mouth as specified |
|
| Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C) | Experimental | BMS-955176 single dose by mouth as specified |
|
| Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B) | Experimental | BMS-955176 single dose by mouth as specified |
|
| Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H) | Experimental | BMS-955176 single dose by mouth as specified |
|
| Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-955176 | Drug | BMS-955176 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 | |
| Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 | |
| Terminal plasma half-life (T-HALF) of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 | |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
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 | Nottingham | NG11 6JS | United Kingdom |
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627567 | BMS-955176 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
BMS-955176 single dose by mouth as specified
|
| Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G) | Experimental | BMS-955176 single dose by mouth as specified |
|
| Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F) | Experimental | BMS-955176 single dose by mouth as specified |
|
| Apparent total body clearance (CLT/F) of BMS-955176 |
| Days 1-4 of Periods 1, 2, 3 and 4 |
| Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations | Up to Period 4/Day 4 (discharge) |
| 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 |