Clinical trial NCT05847439: A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
Official title: A Phase 1, Single-center, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Metabolite profile
Radioactivity
BMS-986419
Healthy volunteer
Healthy participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-05-06
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 pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of \[14C\]BMS-986419 in healthy male participants.


Eligibility criteria: Inclusion Criteria:

* Body mass index between 18.0 and 33.0 kilograms/meter square (kg/m\^2), inclusive, at screening. Body mass index = weight (kg)/(height \[m\])2.
* Healthy male participants as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[for example, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in (Day -2).

Exclusion Criteria:

* Any significant acute or chronic medical conditions.
* Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery (for example, cholecystectomy and any other gastrointestinal surgery) that could impact the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could impact the absorption of study treatment.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 20
measure: Time of maximum plasma observed concentration (Tmax)
timeFrame: Up to Day 20
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
timeFrame: Up to Day 20
measure: Total radioactivity recovered in urine (UR)
timeFrame: Up to Day 30
measure: Total radioactivity recovered in feces (FR)
timeFrame: Up to Day 30
measure: Total radioactivity recovered in bile (BR)
timeFrame: Up to Day 30
measure: Total radioactivity recovered (Rtotal)
timeFrame: Up to Day 30
measure: Percent of total radioactivity recovered (%Total)
timeFrame: Up to Day 30
measure: Percent of total radioactivity recovered in urine (%UR)
timeFrame: Up to Day 30
measure: Percent of total radioactivity recovered in feces (%FR)
timeFrame: Up to Day 30
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 60
measure: Number of Participants with Serious AEs (SAEs)
timeFrame: Up to Day 60
measure: Number of Participants with AEs leading to discontinuation
timeFrame: Up to Day 60
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to Day 30
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 30
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: Up to Day 30
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to Day 30
Other outcomes:
Locations:
city: Madison
country: United States
facility: Labcorp Clinical Research Unit - Madison
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: