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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06227975
• Other study ID #: IM045-1003
• Status: Completed
• Phase: Phase 1
• Start date: February 2, 2024
• Est. completion date: April 3, 2024

Study information

• Verified date: May 2024
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 3, 2024
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]-BMS-986368
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax)		Up to Day 15
Primary	Time of maximum observed concentration (Tmax)		Up to Day 15
Primary	Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))		Up to Day 15
Primary	Total Radioactivity (TRA)		Up to Day 30
Secondary	Number of participants with Adverse Events (AEs)		Up to Day 36
Secondary	Number of participants with Serious AEs (SAEs)		Up to Day 36
Secondary	Number of participants with AEs leading to discontinuation		Up to Day 36
Secondary	Number of participants with vital sign abnormalities		Up to Day 30
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to Day 30
Secondary	Number of participants with physical examination abnormalities		Up to Day 30
Secondary	Number of participants with clinical laboratory test abnormalities		Up to Day 30

External Links

•   BMS Clinical Trial Information