Clinical trial NCT02327273: Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: subjects
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-12-30
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 10 days
measure: 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
timeFrame: With in 18 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development, Lp
state: Texas
Study officials:
References: