Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
Study Classification: Safety, PK/PD
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
Part A SAD: BMS-963272 or Placebo
BMS-963272 or Placebo oral capsule on specific days
Intervention: Placebo
Part A SAD: BMS-963272 or Placebo
BMS-963272 or Placebo oral capsule on specific days
Intervention: BMS-963272
Part B MAD: BMS-963272 or Placebo
BMS-963272 or Placebo oral capsule on specific days
Intervention: BMS-963272
Part B MAD: BMS-963272 or Placebo
BMS-963272 or Placebo oral capsule on specific days
Intervention: Placebo
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: With in 18 days