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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BMS-963272; Drug: Placebo

• Registration Number: NCT02327273
• Lead Sponsor: Bristol-Myers Squibb

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

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-12-24
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-30
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A SAD: BMS-963272 or Placebo	BMS-963272	BMS-963272 or Placebo oral capsule on specific days
Part A SAD: BMS-963272 or Placebo	Placebo	BMS-963272 or Placebo oral capsule on specific days
Part B MAD: BMS-963272 or Placebo	BMS-963272	BMS-963272 or Placebo oral capsule on specific days
Part B MAD: BMS-963272 or Placebo	Placebo	BMS-963272 or Placebo oral capsule on specific days

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ppd Development, Lp; 🇺🇸 Austin, Texas, United States