A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/25/2017 |
| Start Date: | July 28, 2016 |
| End Date: | November 7, 2017 |
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.
well tolerated in healthy male subjects and female subjects of non-childbearing potential.
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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 Criteria:
- 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
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