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

Primary Purpose

Severe Sepsis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986189
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Severe Sepsis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Covance Clinical Research Unit, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BMS-986189

Placebo

Arm Description

Specified Dose on Specified Day

Specified Dose on Specified Day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 8, 2016
Last Updated
February 5, 2018
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02739373
Brief Title
Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 18, 2016 (Actual)
Primary Completion Date
December 14, 2016 (Actual)
Study Completion Date
December 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986189
Arm Type
Experimental
Arm Description
Specified Dose on Specified Day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Specified Dose on Specified Day
Intervention Type
Drug
Intervention Name(s)
BMS-986189
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Maximum observed concentration (Cmax)
Time Frame
Day 1 to Day 30
Title
Time of maximum observed concentration (Tmax)
Time Frame
Day 1 to Day 30
Title
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
Title
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame
Day 1 to Day 30
Title
Half Life (T-HALF)
Time Frame
Day 1 to Day 30
Title
Total Body Clearance (CLT/F)
Time Frame
Day 1 to Day 30
Title
Apparent volume of distribution at steady state (Vss/F)
Time Frame
Day 1 to Day 30
Title
Deaths leading to discontinuation
Time Frame
Day 1 to Day 30
Title
Adverse events (AEs) leading to discontinuation
Time Frame
Day 1 to Day 30
Title
Serious adverse events (SAEs) leading to discontinuation
Time Frame
Day 1 to Day 30
Title
Lab abnormalities leading to discontinuation
Time Frame
Day 1 to Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Covance Clinical Research Unit, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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