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

February 5, 2018 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Covance Clinical Research Unit, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Day 1 to Day 30
Day 1 to Day 30
Time of maximum observed concentration (Tmax)
Time Frame: Day 1 to Day 30
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))
Time Frame: Day 1 to Day 30
Day 1 to Day 30
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame: Day 1 to Day 30
Day 1 to Day 30
Half Life (T-HALF)
Time Frame: Day 1 to Day 30
Day 1 to Day 30
Total Body Clearance (CLT/F)
Time Frame: Day 1 to Day 30
Day 1 to Day 30
Apparent volume of distribution at steady state (Vss/F)
Time Frame: Day 1 to Day 30
Day 1 to Day 30
Deaths leading to discontinuation
Time Frame: Day 1 to Day 30
Day 1 to Day 30
Adverse events (AEs) leading to discontinuation
Time Frame: Day 1 to Day 30
Day 1 to Day 30
Serious adverse events (SAEs) leading to discontinuation
Time Frame: Day 1 to Day 30
Day 1 to Day 30
Lab abnormalities leading to discontinuation
Time Frame: Day 1 to Day 30
Day 1 to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2016

Primary Completion (Actual)

December 14, 2016

Study Completion (Actual)

December 14, 2016

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI006-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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