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

A Phase 1, Single-center, Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-BMS-986368

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

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704-2526
      • Recruiting
      • Labcorp Clinical Research Unit - Madison
      • Contact: Nicholas Siebers, Site 0001; Phone Number: 608-443-1492

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Other protocol-defined incusion/exclusion criteria apply.

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: [14C]-BMS-986368	Drug: [14C]-BMS-986368; Specified dose on specified days; Other Names: CC-97489

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Number of participants with physical examination abnormalities	Up to Day 30
Number of participants with clinical laboratory test abnormalities	Up to Day 30

Collaborators and Investigators

• Sponsor: Celgene
• 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): February 2, 2024
• Primary Completion (Estimated): April 6, 2024
• Study Completion (Estimated): April 6, 2024

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy male volunteers; ADME; CC-97489; BMS-986368
• Other Study ID Numbers: IM045-1003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• 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 Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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