A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants

Healthy Participants Clinical Trial

Official title:

A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 in Healthy Male Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05409157
• Other study ID #: IM018-010
• Status: Completed
• Phase: Phase 1
• Start date: June 17, 2022
• Est. completion date: October 15, 2022

Study information

• Verified date: March 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 assess the drug levels of BMS-986166 in healthy male participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• 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 deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations

• Body mass index between 18.0 to 33.0 kg/m2 (inclusive)

Exclusion Criteria:

• Any significant acute or chronic medical illness

• Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)

• History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986166
Specified dose on specified days
• Bisacodyl
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	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 amount of total radioactivity (TRA) recovered in urine (UR)		Up to 90 days
Primary	Total amount of TRA recovered in feces (FR)		Up to 90 days
Primary	Total amount of TRA recovered in urine and feces combined (RTotal)		Up to 90 days
Primary	Percent of TRA recovered in urine (%UR)		Up to 90 days
Primary	Percent of TRA recovered in feces (%FR)		Up to 90 days
Primary	Percent of TRA recovered in urine and feces combined (%TOTAL)		Up to 90 days
Primary	Maximum observed concentration (Cmax)		Up to 89 days
Primary	Time of maximum observed concentration (Tmax)		Up to 89 days
Primary	Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]		Up to 89 days
Secondary	Number of participants with adverse events (AEs)		Up to 124 days
Secondary	Number of participants with serious adverse events (SAEs)		Up to 124 days
Secondary	Number of participants with vital sign abnormalities		Up to 90 days
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 90 days
Secondary	Number of participants with physical examination abnormalities		Up to 90 days
Secondary	Number of participants with clinical laboratory test abnormalities		Up to 90 days
Secondary	Maximum observed concentration (Cmax)		Up to 89 days
Secondary	Time of maximum observed concentration (Tmax)		Up to 89 days
Secondary	Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]		Up to 89 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting