Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/21/2016 |
Start Date: | September 2014 |
End Date: | September 2015 |
Randomized, Double-Blinded, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and
pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.
pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.
Maximum Age:
Part A SAD 65 years
Part B MAD 75 years
Part C MAD Japanese 75 years
Part A SAD 65 years
Part B MAD 75 years
Part C MAD Japanese 75 years
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
1. Healthy male and female subjects as determined by no clinically significant deviation
from normal in medical history, physical examination, ECGs, and clinical laboratory
determinations
2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/[height(m)]2
3. Women who are not of childbearing potential (i.e., who are postmenopausal or
surgically sterile) and men, ages 18 to 75, inclusive
Exclusion Criteria:
1. Concurrent or use within 2 weeks of study drug administration, of marketed or
investigational, drugs as specified in protocol
2. Other protocol-defined exclusion criteria could apply
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