Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single oral dose of BMS-963272 in healthy overweight and obese subjects is measured by adverse events, Serious adverse events, vital signs, laboratory assessments and ECG
研究概览
简要总结
The purpose of this study is to evaluate the safety profile, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) following single and multiple oral doses of BMS-963272 in healthy subjects.
详细描述
Study Classification: Safety, PK/PD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
- •Body Mass Index (BMI) of 27 to 40 kg/m2 inclusive. BMI = weight (kg)/ [height (m)]2
- •Females (not of childbearing potential and males, ages 18 to 55 years, inclusive. Female subjects must have documented proof that they are not of childbearing potential
- •Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section
排除标准
- •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
- •Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat.
- •i)PR ≥ 210 msec ii)QRS ≥ 120 msec iii)QT ≥ 500 msec iv)QTcF ≥ 450 msec
- •Positive urine screen for drugs of abuse
- •Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
- •Moderate anemia (hemoglobin < 11 g/dL for men and < 10 g/dL for women)
- •aspartate aminotransferase (AST) > 1.3x ULN
- •alanine aminotransferase (ALT) > 1.3x ULN
- •Total bilirubin > 1.3x upper limit of normal (ULN)
- •estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73 m2 (calculated using CKD-EPI formula)
- •HbA1c > 6.5%
- •Fasting total cholesterol > 300 mg/dl
- •Fasting triglycerides > 400 mg/dl
- •Systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 95 mm Hg, confirmed by repeat measurement
- •History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
- •History of lactose intolerance
研究组 & 干预措施
Part A SAD: BMS-963272 or Placebo
BMS-963272 or Placebo oral capsule on specific days
干预措施: Placebo (Drug)
Part A SAD: BMS-963272 or Placebo
BMS-963272 or Placebo oral capsule on specific days
干预措施: BMS-963272 (Drug)
Part B MAD: BMS-963272 or Placebo
BMS-963272 or Placebo oral capsule on specific days
干预措施: BMS-963272 (Drug)
Part B MAD: BMS-963272 or Placebo
BMS-963272 or Placebo oral capsule on specific days
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of single oral dose of BMS-963272 in healthy overweight and obese subjects is measured by adverse events, Serious adverse events, vital signs, laboratory assessments and ECG
时间窗: Up to 10 days
Safety and tolerability of multiple oral doses of BMS-963272 in healthy overweight and obese subjects is measured by adverse events, Serious adverse events, vital signs, laboratory assessments and ECG
时间窗: With in 18 days
次要结局
未报告次要终点