Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/9/2018 |
| Start Date: | April 18, 2016 |
| End Date: | December 14, 2016 |
Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
The main purpose of this study is to measure the amount of study drug (BMS-986189) in the
blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a
single dose.
blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a
single dose.
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Healthy, males and females, 18 to 55 years of age, inclusive
- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive
- Women of childbearing potential (WOCBP) must have negative serum pregnancy test
(performed for all females; minimum sensitivity 25 IU/L or equivalent units of human
chorionic gonadotropin) within 24 hours prior to start of study drug
Exclusion Criteria:
- Any significant acute or chronic medical illness
- History of diabetes mellitus, severe hypertriglyceridemia, acute or chronic
pancreatitis, pancreatic exocrine disorder
- History of autoimmune disease
- Any known skin condition that would affect subcutaneous dosing
- Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen
(HBsAg), or HIV -1 and HIV -2 antibody
Other protocol defined inclusion/exclusion criteria could apply
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