Clinical trial NCT04269356: Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants
Official title: Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Recruitment temporarily on hold due to COVID-19.

Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of [14C] BMS-986256
timeFrame: Up to 49 days
measure: Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256
timeFrame: Up to 49 days
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256
timeFrame: Up to 49 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 49 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 49 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 49 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to 49 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 49 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 49 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 49 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 49 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 49 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters
timeFrame: Up to 49 days
measure: Incidence of clinically significant changes in physical examination findings
timeFrame: Up to 49 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance - Clinical Pharmacology Services - Madison
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: