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

NCT ID: NCT02327273

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-05-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Part A SAD: BMS-963272 or Placebo

BMS-963272 or Placebo oral capsule on specific days

Group Type: EXPERIMENTAL

BMS-963272

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Part B MAD: BMS-963272 or Placebo

BMS-963272 or Placebo oral capsule on specific days

Group Type: EXPERIMENTAL

BMS-963272

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

BMS-963272

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ppd Development, Lp

Austin, Texas, United States

Countries

United States

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

MB006-002

Identifier Type: -

Identifier Source: org_study_id