Clinical trial NCT04567667: Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants
Official title: Pharmacokinetics and Metabolism of [14C] BMS-986278 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 9
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.


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

Inclusion Criteria:

* No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations
* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb), at screening. BMI = weight (kg)/(height \[m\])2
* Males must agree to follow specific methods of contraception, if applicable

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, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
* Any major surgery within 6 weeks of study treatment administration

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986278
timeFrame: Up to 15 days
measure: Maximum observed plasma concentration (Cmax) of total radioactivity (TRA)
timeFrame: Up to 15 days
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986278
timeFrame: Up to 15 days
measure: Time of maximum observed plasma concentration (Tmax) of TRA
timeFrame: Up to 15 days
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of BMS-986278
timeFrame: Up to 15 days
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of TRA
timeFrame: Up to 15 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 15 days
measure: Incidence of Serious Adverse Events (AEs)
timeFrame: Up to 73 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 43 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to 43 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 43 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 43 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 43 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 43 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 43 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
timeFrame: Up to 43 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
timeFrame: Up to 43 days
measure: Incidence of clinically significant changes in physical examination findings
timeFrame: Up to 43 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: