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

NCT05981963 | Completed Phase 1 FDA Drug

• 1 other identifier: IM038-1007
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Male Volunteers

Keywords

Pharmacokinetics; BMS-986196; Healthy male volunteers; [14C]-BMS-986196; Total radioactivity

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (10)

• 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

Study Arms (1)

[14C]-BMS-986196

EXPERIMENTAL

Drug: [14C]-BMS-986196

Interventions

[14C]-BMS-986196 DRUG

Specified dose on specified days

Also known as: BMS-986196

[14C]-BMS-986196

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Labcorp Clinical Research Unit - Madison

Madison, Wisconsin, 53704-2526, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: August 17, 2023
• Primary Completion: October 22, 2023
• Study Completion: October 22, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)