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This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-963272 or Placebo once daily (QD) | Experimental |
| |
| BMS-963272 or Placebo every 12 hours (Q12H) | Experimental |
| |
| BMS-963272 or Placebo every 8 hours (Q8H) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-963272 | Drug | Single dose with varying frequency among groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of BMS-963272 (Cmax) | Day 1, Day 14 | |
| Time of maximum observed concentration of BMS-963272 (Tmax) | Day 1, Day 14 | |
| Area under the concentration-time curve in one dosing interval (AUC(TAU)) | Day 1, Day 14 | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) | Day 14 | |
| Apparent total clearance of the drug from plasma after oral administration (CLss/F) | Day 14 | |
| Apparent volume of distribution at steady state (Vss/F) | Day 14 | |
| Average concentration at steady state (Cavg,ss) | Day 14 | |
| Half-life (T-HALF) | Day 14 | |
| Accumulation index (AI) | Day 14 | |
| Rate elimination constant (kel) of BMS-963272 | Day 14 | |
| Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 55 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 55 days | |
| Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences - Lenexa | Lenexa | Kansas | 66219 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Placebo | Drug | Specified dose on specified days |
|
| Day 7, Day 15 |
| Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT | Day 7, Day 15 |
| Up to 55 days |
| FDA Safety Alerts and Recalls | View source |