Pharmacokinetics and Metabolism Study of Radiolabeled BMS-986142 in Healthy Male Subjects
Primary Purpose
Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986142
Sponsored by

About this trial
This is an interventional treatment trial for Arthritis focused on measuring Rheumatoid
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent
- Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
- Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.
Exclusion Criteria:
- History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
- Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
- History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.
- Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.
Sites / Locations
- Covance Clinical Research Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single dose of radiolabeled BMS-986142
Arm Description
Outcomes
Primary Outcome Measures
The primary endpoint is PK parameters that will be determined from plasma concentration versus time
Urinary/fecal/bile (if applicable) TRA (Total radioactivity) recovery data
Secondary Outcome Measures
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and the results of electrocardiogram tests (ECGs), vital signs, physical exams, and clinical laboratory tests.
Full Information
NCT ID
NCT02880670
First Posted
August 15, 2016
Last Updated
November 15, 2016
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT02880670
Brief Title
Pharmacokinetics and Metabolism Study of Radiolabeled BMS-986142 in Healthy Male Subjects
Official Title
Pharmacokinetics and Metabolism of [14C] BMS-986142 in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 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
This is an open-label, single-dose, study in healthy males. The primary objective is to assess the pharmacokinetics (PK), metabolism, and routes of elimination of a single oral dose of radiolabeled BMS-986142 in healthy male subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
Rheumatoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single dose of radiolabeled BMS-986142
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986142
Primary Outcome Measure Information:
Title
The primary endpoint is PK parameters that will be determined from plasma concentration versus time
Time Frame
Day 1 to Day 13
Title
Urinary/fecal/bile (if applicable) TRA (Total radioactivity) recovery data
Time Frame
Day 1 to Day 13
Secondary Outcome Measure Information:
Title
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and the results of electrocardiogram tests (ECGs), vital signs, physical exams, and clinical laboratory tests.
Time Frame
Day 1 to Day 13
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent
Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.
Exclusion Criteria:
History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.
Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.
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
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.bms.com/studyconnect/pages/home.aspx
Description
BMS Clinical Trial Education Resource
Learn more about this trial
Pharmacokinetics and Metabolism Study of Radiolabeled BMS-986142 in Healthy Male Subjects
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