Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
1 other identifier
interventional
76
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedStudy Start
First participant enrolled
April 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2016
CompletedFebruary 7, 2018
February 1, 2018
8 months
April 8, 2016
February 5, 2018
Conditions
Outcome Measures
Primary Outcomes (11)
Maximum observed concentration (Cmax)
Day 1 to Day 30
Time of maximum observed concentration (Tmax)
Day 1 to Day 30
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(O-T))
Day 1 to Day 30
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Day 1 to Day 30
Half Life (T-HALF)
Day 1 to Day 30
Total Body Clearance (CLT/F)
Day 1 to Day 30
Apparent volume of distribution at steady state (Vss/F)
Day 1 to Day 30
Deaths leading to discontinuation
Day 1 to Day 30
Adverse events (AEs) leading to discontinuation
Day 1 to Day 30
Serious adverse events (SAEs) leading to discontinuation
Day 1 to Day 30
Lab abnormalities leading to discontinuation
Day 1 to Day 30
Study Arms (2)
BMS-986189
EXPERIMENTALSpecified Dose on Specified Day
Placebo
PLACEBO COMPARATORSpecified Dose on Specified Day
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Research Unit, Inc.
Evansville, Indiana, 47710, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2016
First Posted
April 15, 2016
Study Start
April 18, 2016
Primary Completion
December 14, 2016
Study Completion
December 14, 2016
Last Updated
February 7, 2018
Record last verified: 2018-02