A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants

A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986322 in Healthy Adult Male Participants

The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.

Study Overview

• Status: Completed
• Conditions: Healthy Male Participants
• Intervention / Treatment: Drug: BMS-986322

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Fortrea Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of BMS-986322	Drug: BMS-986322; Specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed in plasma/whole blood concentration (Cmax)	Up to day 17
Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	Up to day 17
Area under the plasma/whole blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))	Up to day 17
Time of maximum observed in plasma/whole blood concentration (T-max)	Up to day 17
Terminal elimination half-life (T-HALF)	Up to day 17
Apparent total body clearance (CL/F)	Up to day 17
Apparent volume of distribution of terminal phase (Vz/F)	Up to day 17
Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF))	Up to day 17
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)	Up to day 17
Total amount of radioactivity recovered in urine (UR)	Up to day 17
Percent of total amount of radioactivity recovered in urine (%UR)	Up to day 17
Total amount of radioactivity recovered in feces (FR)	Up to day 17
Percent of total amount of radioactivity recovered in feces (%FR)	Up to day 17
Total amount of radioactivity recovered in urine and feces combined (RTotal)	Up to day 17
Percent of total amount of radioactivity recovered in all excreta (%Total)	Up to day 17

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events (AEs)	Up to day 47
Number of participants with serious adverse events (SAEs)	Up to day 47
Number of participants with AEs leading to discontinuation	Up to day 47
Number of participants with vital sign abnormalities	Up to day 17
Number of participants with electrocardiogram (ECG) abnormalities	Up to day 17
Number of participants with clinically significant physical examination findings	Up to day 17
Number of participants with clinical laboratory abnormalities	Up to day 17

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IM032-1018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/ disclosure-commitment.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No