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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BMS-963272; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02327273

MB006-002

Details and patient eligibility

About

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.

Full description

Study Classification: Safety, PK/PD

Enrollment: 88 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

Part A SAD: BMS-963272 or Placebo

Experimental group

Description:

BMS-963272 or Placebo oral capsule on specific days

Treatment:

Drug: Placebo

Drug: BMS-963272

Part B MAD: BMS-963272 or Placebo

Experimental group

Description:

BMS-963272 or Placebo oral capsule on specific days

Treatment:

Drug: Placebo

Drug: BMS-963272