Healthy
Conditions
Keywords
subjects
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
Interventions
DRUGBMS-963272
DRUGPlacebo
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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) * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 | With in 18 days |
Countries
United States
Outcome results
None listed