A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants

NCT06227975 | Completed Phase 1 FDA Drug

• 1 other identifier: IM045-1003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy male participants.

Conditions

Healthy Volunteers

Keywords

ADME; Healthy male volunteers; Pharmacokinetics; BMS-986368; CC-97489

Outcome Measures

Primary Outcomes (4)

• Maximum observed concentration (Cmax)

  Up to Day 15

• Time of maximum observed concentration (Tmax)

  Up to Day 15

• Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))

  Up to Day 15

• Total Radioactivity (TRA)

  Up to Day 30

Secondary Outcomes (7)

• Number of participants with Adverse Events (AEs)

  Up to Day 36

• Number of participants with Serious AEs (SAEs)

  Up to Day 36

• Number of participants with AEs leading to discontinuation

  Up to Day 36

• Number of participants with vital sign abnormalities

  Up to Day 30

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to Day 30

Study Arms (1)

[14C]-BMS-986368

EXPERIMENTAL

Drug: [14C]-BMS-986368

Interventions

[14C]-BMS-986368 DRUG

Specified dose on specified days

Also known as: CC-97489

[14C]-BMS-986368

Eligibility Criteria

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

You may qualify if:

• Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator.
• Body mass index of 18.0 to 35.0 kg/m2, inclusive. Body mass index = weight (kg)/(height\[m\])\^2

You may not qualify if:

• History of hypokalemia.
• Any significant acute or chronic medical illness as determined by the investigator.
• Participant has a history of syncope in the year prior to Day 1.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Local Institution - 0001

Madison, Wisconsin, 53704-2526, 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: January 19, 2024
• First Posted: January 29, 2024
• Study Start: February 2, 2024
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1)