Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects

Study Classification: Safety, PK/PD

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