A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Time of maximum observed concentration of BMS-963272 (Tmax)
研究概览
简要总结
This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BMS-963272 or Placebo once daily (QD)
干预措施: BMS-963272 (Drug)
BMS-963272 or Placebo once daily (QD)
干预措施: Placebo (Drug)
BMS-963272 or Placebo every 12 hours (Q12H)
干预措施: BMS-963272 (Drug)
BMS-963272 or Placebo every 12 hours (Q12H)
干预措施: Placebo (Drug)
BMS-963272 or Placebo every 8 hours (Q8H)
干预措施: BMS-963272 (Drug)
BMS-963272 or Placebo every 8 hours (Q8H)
干预措施: Placebo (Drug)
结局指标
主要结局
Time of maximum observed concentration of BMS-963272 (Tmax)
时间窗: Day 1, Day 14
Maximum observed plasma concentration of BMS-963272 (Cmax)
时间窗: Day 1, Day 14
Area under the concentration-time curve in one dosing interval (AUC(TAU))
时间窗: Day 1, Day 14
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
时间窗: Day 14
Apparent total clearance of the drug from plasma after oral administration (CLss/F)
时间窗: Day 14
Apparent volume of distribution at steady state (Vss/F)
时间窗: Day 14
Average concentration at steady state (Cavg,ss)
时间窗: Day 14
Half-life (T-HALF)
时间窗: Day 14
Accumulation index (AI)
时间窗: Day 14
Rate elimination constant (kel) of BMS-963272
时间窗: Day 14
Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT)
时间窗: Day 7, Day 15
Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT
时间窗: Day 7, Day 15
次要结局
- 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)