Obese But Otherwise Healthy Participants
Conditions
Brief summary
This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.
Interventions
DRUGBMS-963272
Single dose with varying frequency among groups
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT | Day 7, Day 15 |
| Area under the concentration-time curve in one dosing interval (AUC(TAU)) | Day 1, Day 14 |
| Maximum observed plasma concentration of BMS-963272 (Cmax) | Day 1, 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 |
| 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 |
| Time of maximum observed concentration of BMS-963272 (Tmax) | Day 1, Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of Adverse Events (AEs) | Up to 55 days |
Countries
United States
Outcome results
None listed