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

Healthy Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05981963
• Other study ID #: IM038-1007
• Status: Completed
• Phase: Phase 1
• Start date: August 17, 2023
• Est. completion date: October 22, 2023

Study information

• Verified date: November 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 22, 2023
• Est. primary completion date: October 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• [14C]-BMS-986196
Specified dose on specified days

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit - Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax)		Up to Day 15
Primary	TRA: Time of Cmax (Tmax)		Up to Day 15
Primary	TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])		Up to Day 15
Primary	TRA: Amount of radioactivity recovered in urine (UR)		Up to Day 15
Primary	TRA: Amount of radioactivity recovered in feces (FR)		Up to Day 15
Primary	TRA: Amount of radioactivity recovered in bile (BR)		Up to 14 hours post dose
Primary	TRA: Percent of administered dose recovered in urine (%UR)		Up to Day 15
Primary	TRA: Percent of administered dose recovered in feces (%FR)		Up to Day 15
Primary	TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)		Up to Day 15
Secondary	Cmax		Up to Day 15
Secondary	Tmax		Up to Day 15
Secondary	AUC (0-T)		Up to Day 15
Secondary	Number of Participants with Adverse Events (AEs)		Up to Day 29
Secondary	Number of Participants with Serious AEs (SAEs)		Up to Day 29
Secondary	Number of Participants with AEs Leading to Discontinuation		Up to Day 29
Secondary	Number of Participants with Vital Sign Abnormalities		Up to Day 15
Secondary	Number of Participants with Electrocardiogram (ECG) Abnormalities		Up to Day 15
Secondary	Number of Participants with Physical Examination Abnormalities		Up to Day 15
Secondary	Number of Participants with Clinical Laboratory Abnormalities		Up to Day 15

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting