Not provided
Not provided
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 assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.
Primary Purpose
Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (ABDC): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified |
|
| Arm 2 (BCAD): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified |
|
| Arm 3 (CDBA): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified |
|
| Arm 4 (DACB): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified |
|
| Arm 5 (EFHG): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified |
|
| Arm 6 (FGEH): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-955176 | Drug | Single dose by mouth for each treatment specified |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) for BMS-955176 | Up to Day 4 of Period 4 | |
| Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176 | Up to Day 4 of Period 4 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176 | Up to Day 4 of Period 4 | |
| Plasma concentration at 24 hours post-dose (C24) for BMS-955176 | Up to Day 4 of Period 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG) | 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 | Ruddington Fields | Nottinghamshire | 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
|
| Arm 7 (GHFE): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified |
|
| Arm 8 (HEGF): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified |
|
| Arm 9 (IJK): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 10 (JKI): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 11 (KIJ): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 12 (IKJ): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 13 (JIK): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 14 (KJI): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 15 (LMN): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 16 (OPQ): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 17 (PQO): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 18 (QOP): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 19 (OQP): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 20 (POQ): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| Arm 21 (QPO): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified |
|
| 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 |