A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants

A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of Orally Administered 60 mg BMS-986196, Including Radioactively Labeled [14C]-BMS-986196, in Healthy Male Participants

The purpose of this study is to evaluate the excretion pathway of orally administered [14C]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.

Study Overview

• Status: Recruiting
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: [14C]-BMS-986196

• 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: Sarah Russell, Site 0001; Phone Number: 608-210-5574
    • Madison, Wisconsin, United States, 53704-2526
      • Withdrawn
      • Covance Clinical Research Unit - Madison

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Healthy male participants without clinically significant deviation from normal in medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day -1 physical examination.
• Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and total body weight ≥ 50 kg

Exclusion Criteria:

• Any significant acute or chronic medical illness as determined by the investigator.
• A history of clinically significant hepatic or pancreatic disease.
• Current or recent (within 3 months prior to study treatment administration) gastrointestinal disease that could impact upon the absorption, distribution, metabolism, or excretion of study treatment as determined by the investigator.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-BMS-986196	Drug: [14C]-BMS-986196; Specified dose on specified days; Other Names: BMS-986196

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax)	Up to Day 15
TRA: Time of Cmax (Tmax)	Up to Day 15
TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])	Up to Day 15
TRA: Amount of radioactivity recovered in urine (UR)	Up to Day 15
TRA: Amount of radioactivity recovered in feces (FR)	Up to Day 15
TRA: Amount of radioactivity recovered in bile (BR)	Up to 14 hours post dose
TRA: Percent of administered dose recovered in urine (%UR)	Up to Day 15
TRA: Percent of administered dose recovered in feces (%FR)	Up to Day 15
TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)	Up to Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax	Up to Day 15
Tmax	Up to Day 15
AUC (0-T)	Up to Day 15
Number of Participants with Adverse Events (AEs)	Up to Day 29
Number of Participants with Serious AEs (SAEs)	Up to Day 29
Number of Participants with AEs Leading to Discontinuation	Up to Day 29
Number of Participants with Vital Sign Abnormalities	Up to Day 15
Number of Participants with Electrocardiogram (ECG) Abnormalities	Up to Day 15
Number of Participants with Physical Examination Abnormalities	Up to Day 15
Number of Participants with Clinical Laboratory Abnormalities	Up to Day 15

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
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Estimated): October 22, 2023
• Study Completion (Estimated): October 22, 2023

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy male volunteers; BMS-986196; [14C]-BMS-986196; Total radioactivity
• Other Study ID Numbers: IM038-1007

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-and-research/disclosurecommitment.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