Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects
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Lead
Bristol-Myers Squibb
Study Classification: Safety, PK/PD
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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 be 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.
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
Clareo Health | Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects
