Clinical trial NCT06088264: A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants
Official title: A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986322 in Healthy Adult Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 8
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 evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.


Eligibility criteria: Inclusion Criteria:

* Participants must have a body mass index of 18.0 to 32.0 kg/m2, inclusive.
* Participants will be required to always use a latex or other synthetic condom with spermicide during any sexual activity
* Participants must refrain from donating sperm during the entire study and for at least 90 days from dose of study drug.

Exclusion Criteria:

* Participant must not have had any clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months prior to admission to the clinic.
* Participant must not be currently employed in a job requiring radiation exposure monitoring.
* Participant must not have had any major surgery within 4 weeks of study drug administration that could impact upon the absorption of study drug

Primary outcomes:
measure: Maximum observed in plasma/whole blood concentration (Cmax)
timeFrame: Up to day 17
measure: Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to day 17
measure: Area under the plasma/whole blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to day 17
measure: Time of maximum observed in plasma/whole blood concentration (T-max)
timeFrame: Up to day 17
measure: Terminal elimination half-life (T-HALF)
timeFrame: Up to day 17
measure: Apparent total body clearance (CL/F)
timeFrame: Up to day 17
measure: Apparent volume of distribution of terminal phase (Vz/F)
timeFrame: Up to day 17
measure: Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF))
timeFrame: Up to day 17
measure: Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)
timeFrame: Up to day 17
measure: Total amount of radioactivity recovered in urine (UR)
timeFrame: Up to day 17
measure: Percent of total amount of radioactivity recovered in urine (%UR)
timeFrame: Up to day 17
measure: Total amount of radioactivity recovered in feces (FR)
timeFrame: Up to day 17
measure: Percent of total amount of radioactivity recovered in feces (%FR)
timeFrame: Up to day 17
measure: Total amount of radioactivity recovered in urine and feces combined (RTotal)
timeFrame: Up to day 17
measure: Percent of total amount of radioactivity recovered in all excreta (%Total)
timeFrame: Up to day 17
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to day 47
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to day 47
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to day 47
measure: Number of participants with vital sign abnormalities
timeFrame: Up to day 17
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to day 17
measure: Number of participants with clinically significant physical examination findings
timeFrame: Up to day 17
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to day 17
Other outcomes:
Locations:
city: Madison
country: United States
facility: Fortrea Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: