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

NCT06088264 | Completed Phase 1 FDA Drug

• 1 other identifier: IM032-1018
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male Participants

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (7)

• 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

Study Arms (1)

Administration of BMS-986322

EXPERIMENTAL

Drug: BMS-986322

Interventions

BMS-986322 DRUG

Specified dose on specified days.

Administration of BMS-986322

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Related Links

• BMS Clinical Trial Information

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: October 31, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)