Clinical trial NCT05981963: A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants
Official title: A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of Orally Administered 60 mg BMS-986196, Including Radioactively Labeled [14C]-BMS-986196, in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Keywords: Pharmacokinetics
BMS-986196
Healthy male volunteers
[14C]-BMS-986196
Total radioactivity
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-08-08
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 evaluate the excretion pathway of orally administered \[14C\]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.


Eligibility criteria: Inclusion Criteria:

* Healthy male participants without clinically significant deviation from normal in medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day -1 physical examination.
* Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and total body weight ≥ 50 kg

Exclusion Criteria:

* Any significant acute or chronic medical illness as determined by the investigator.
* A history of clinically significant hepatic or pancreatic disease.
* Current or recent (within 3 months prior to study treatment administration) gastrointestinal disease that could impact upon the absorption, distribution, metabolism, or excretion of study treatment as determined by the investigator.

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

Primary outcomes:
measure: Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 15
measure: TRA: Time of Cmax (Tmax)
timeFrame: Up to Day 15
measure: TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
timeFrame: Up to Day 15
measure: TRA: Amount of radioactivity recovered in urine (UR)
timeFrame: Up to Day 15
measure: TRA: Amount of radioactivity recovered in feces (FR)
timeFrame: Up to Day 15
measure: TRA: Amount of radioactivity recovered in bile (BR)
timeFrame: Up to 14 hours post dose
measure: TRA: Percent of administered dose recovered in urine (%UR)
timeFrame: Up to Day 15
measure: TRA: Percent of administered dose recovered in feces (%FR)
timeFrame: Up to Day 15
measure: TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)
timeFrame: Up to Day 15
Secondary outcomes:
measure: Cmax
timeFrame: Up to Day 15
measure: Tmax
timeFrame: Up to Day 15
measure: AUC (0-T)
timeFrame: Up to Day 15
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 29
measure: Number of Participants with Serious AEs (SAEs)
timeFrame: Up to Day 29
measure: Number of Participants with AEs Leading to Discontinuation
timeFrame: Up to Day 29
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to Day 15
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 15
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: Up to Day 15
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to Day 15
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: