Expired Study
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Austin, Texas 78744


Purpose:

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.


Study summary:

Study Classification: Safety, PK/PD


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


NCT ID:

NCT02327273


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Austin, Texas 78744
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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