Status:
COMPLETED
A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects of non-childbearing potential.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Healthy female subjects of non-childbearing potential or male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations
- Ages 18 to 55 years
- Female subjects must provide documentation of an acceptable method of surgical sterilization or meet the protocol criteria for menopause
Exclusion
- Any acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor
- Any acute or chronic bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C, as defined in the protocol
- History of heart disease, neurological disease, eye disorders or gastrointestinal disorders or surgery (including cholecystectomy)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs or clinical laboratory tests
- Smoking or nicotine use, drug or alcohol abuse within 6 months of starting the study
- Other protocol defined inclusion/exclusion criteria could apply
Key Trial Info
Start Date :
July 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 7 2017
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02790125
Start Date
July 28 2016
End Date
November 7 2017
Last Update
November 24 2017
Active Locations (1)
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1
PPD Development, LLC
Austin, Texas, United States, 78744