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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02327273
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
7
Duration (Months)
12.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Study Classification: Safety, PK/PD

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
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 Start Date :
Oct 1, 2014
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A SAD: BMS-963272 or Placebo

BMS-963272 or Placebo oral capsule on specific days

Drug: BMS-963272

Drug: Placebo
Experimental: Part B MAD: BMS-963272 or Placebo

BMS-963272 or Placebo oral capsule on specific days

Drug: BMS-963272

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ppd Development, Lp Austin Texas United States 78744

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02327273
Other Study ID Numbers:
  • MB006-002
First Posted:
Dec 30, 2014
Last Update Posted:
Jul 22, 2015
Last Verified:
Jul 1, 2015
Keywords provided by Bristol-Myers Squibb
subjects

Study Results

No Results Posted as of Jul 22, 2015