Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Severe Sepsis

In brief

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.

Key facts

Study ID

NCT02739373

Run by

Bristol-Myers Squibb

People needed

76

Starts

2016-04-18

Expected to finish

2016-12-14

Last updated by the study team

2018-02-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance Clinical Research Unit, Inc. — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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