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OpenTrials
Completed

NCT Number: NCT02739373

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.

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Evansville, Indiana, 47710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986189

Drug

Placebo

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2016
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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