Clinical trial NCT05409157: A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants
Official title: A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 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: 2022-06-08
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.


Eligibility criteria: Inclusion Criteria:

* Healthy male participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations
* Body mass index between 18.0 to 33.0 kg/m2 (inclusive)

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)
* History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Total amount of total radioactivity (TRA) recovered in urine (UR)
timeFrame: Up to 90 days
measure: Total amount of TRA recovered in feces (FR)
timeFrame: Up to 90 days
measure: Total amount of TRA recovered in urine and feces combined (RTotal)
timeFrame: Up to 90 days
measure: Percent of TRA recovered in urine (%UR)
timeFrame: Up to 90 days
measure: Percent of TRA recovered in feces (%FR)
timeFrame: Up to 90 days
measure: Percent of TRA recovered in urine and feces combined (%TOTAL)
timeFrame: Up to 90 days
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 89 days
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 89 days
measure: Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
timeFrame: Up to 89 days
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 124 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 124 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 90 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 90 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 90 days
measure: Number of participants with clinical laboratory test abnormalities
timeFrame: Up to 90 days
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 89 days
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 89 days
measure: Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
timeFrame: Up to 89 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Local Institution - 0001
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: