ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02739373
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Drug: BMS-986189 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
Actual Study Start Date : April 18, 2016
Actual Primary Completion Date : December 14, 2016
Actual Study Completion Date : December 14, 2016

Arm Intervention/treatment
Experimental: BMS-986189
Specified Dose on Specified Day
Drug: BMS-986189
Placebo Comparator: Placebo
Specified Dose on Specified Day
Other: Placebo



Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) [ Time Frame: Day 1 to Day 30 ]
  2. Time of maximum observed concentration (Tmax) [ Time Frame: Day 1 to Day 30 ]
  3. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(O-T)) [ Time Frame: Day 1 to Day 30 ]
  4. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [ Time Frame: Day 1 to Day 30 ]
  5. Half Life (T-HALF) [ Time Frame: Day 1 to Day 30 ]
  6. Total Body Clearance (CLT/F) [ Time Frame: Day 1 to Day 30 ]
  7. Apparent volume of distribution at steady state (Vss/F) [ Time Frame: Day 1 to Day 30 ]
  8. Deaths leading to discontinuation [ Time Frame: Day 1 to Day 30 ]
  9. Adverse events (AEs) leading to discontinuation [ Time Frame: Day 1 to Day 30 ]
  10. Serious adverse events (SAEs) leading to discontinuation [ Time Frame: Day 1 to Day 30 ]
  11. Lab abnormalities leading to discontinuation [ Time Frame: Day 1 to Day 30 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739373


Locations
United States, Indiana
Covance Clinical Research Unit, Inc.
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02739373     History of Changes
Other Study ID Numbers: AI006-003
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes