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

NCT02327273 | Completed Phase 1

• 1 other identifier: MB006-002
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

subjects

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Part A SAD: BMS-963272 or Placebo

EXPERIMENTAL

BMS-963272 or Placebo oral capsule on specific days

Drug: BMS-963272; Drug: Placebo

Part B MAD: BMS-963272 or Placebo

EXPERIMENTAL

BMS-963272 or Placebo oral capsule on specific days

Drug: BMS-963272; Drug: Placebo

Interventions

BMS-963272 DRUG

Part A SAD: BMS-963272 or Placebo; Part B MAD: BMS-963272 or Placebo

Placebo DRUG

Part A SAD: BMS-963272 or Placebo; Part B MAD: BMS-963272 or Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Ppd Development, Lp

Austin, Texas, 78744, United States

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: December 30, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

US (1)