Overview
Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
Status:
Completed
Completed
Trial end date:
2016-12-14
2016-12-14
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bristol-Myers Squibb
Criteria
For more information regarding BMS clinical trial participation, please visitwww.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