A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
Phase 1
Completed
- Conditions
- Obese But Otherwise Healthy Participants
- Interventions
- Drug: BMS-963272Drug: Placebo
- Registration Number
- NCT04116632
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-963272 or Placebo every 12 hours (Q12H) BMS-963272 - BMS-963272 or Placebo once daily (QD) BMS-963272 - BMS-963272 or Placebo once daily (QD) Placebo - BMS-963272 or Placebo every 12 hours (Q12H) Placebo - BMS-963272 or Placebo every 8 hours (Q8H) Placebo - BMS-963272 or Placebo every 8 hours (Q8H) BMS-963272 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
PRA Health Sciences - Lenexa
🇺🇸Lenexa, Kansas, United States