A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.

Official Title
-----------------
A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults

Conditions
-----------------
Obese But Otherwise Healthy Participants

Intervention / Treatment
-----------------
* Drug: BMS-963272
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Participants must be in good general health, in the opinion of the investigator, with no clinically significant deviation from normal in medical history, physical examination findings, ECGs, or laboratory results. Participants must have a BMI of 30 kg/m2 to 40 kg/m2 inclusive Women (not of childbearing potential) and men aged 18 to 60 years, inclusive Exclusion Criteria: Previous participation in the current study Inability or unwillingness to comply with protocol-defined restrictions or requirements regarding lifestyle, diet, concomitant medications, or other aspects of the study Inability to tolerate the oLTT meal or to comply with oLTT testing conditions Inability to tolerate oral medication Inability to tolerate venipuncture and/or inadequate venous access Women who are breastfeeding Medical Conditions History of lactose intolerance Any significant (in the opinion of the investigator) acute or chronic illness Type 1 or 2 diabetes Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population Previous/Concomitant Therapy Previous exposure to BMS-963272 Other protocol-defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-963272 or Placebo once daily (QD)<br> | Drug: BMS-963272<br>* Single dose with varying frequency among groups<br>Drug: Placebo<br>* Specified dose on specified days<br>|
| Experimental: BMS-963272 or Placebo every 12 hours (Q12H)<br> | Drug: BMS-963272<br>* Single dose with varying frequency among groups<br>Drug: Placebo<br>* Specified dose on specified days<br>|
| Experimental: BMS-963272 or Placebo every 8 hours (Q8H)<br> | Drug: BMS-963272<br>* Single dose with varying frequency among groups<br>Drug: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) |  | Day 7, Day 15 | 
| Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT |  | Day 7, Day 15 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Up to 55 days |