A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02790125
- Run by
- Bristol-Myers Squibb
- People needed
- 66
- Starts
- 2016-07-28
- Expected to finish
- 2017-11-07
- Last updated by the study team
- 2017-11-24
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- PPD Development, LLC — Austin, Texas, United States
Full record on ClinicalTrials.gov
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