Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants
Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants
1 other identifier
interventional
8
1 country
1
Brief Summary
The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedStudy Start
First participant enrolled
February 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedJanuary 10, 2022
December 1, 2021
1.1 years
February 12, 2020
December 19, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax) of [14C] BMS-986256
Up to 49 days
Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256
Up to 49 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256
Up to 49 days
Secondary Outcomes (11)
Incidence of Adverse Events (AEs)
Up to 49 days
Incidence of Serious Adverse Events (SAEs)
Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Up to 49 days
- +6 more secondary outcomes
Study Arms (1)
BMS-986256
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy participants, as determined by no clinically significant deviations from normal in medical history, physical examination abnormalities that would compromise the ability to participate, complete, and/or interpret the results of the study, 12-lead electrocardiograms (ECGs), vital signs, and clinical laboratory results.
- Males must agree to follow specific methods of contraception, if applicable, while participating in the trial
You may not qualify if:
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
- History of any significant drug and/or food allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance - Clinical Pharmacology Services - Madison
Madison, Wisconsin, 53704, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 13, 2020
Study Start
February 18, 2020
Primary Completion
March 30, 2021
Study Completion
March 30, 2021
Last Updated
January 10, 2022
Record last verified: 2021-12