Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04269356
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986256; Drug: Milk of magnesia	Phase 1

Detailed Description

Recruitment temporarily on hold due to COVID-19.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants
• Actual Study Start Date: Feb 18, 2020
• Actual Primary Completion Date: Mar 30, 2021
• Actual Study Completion Date: Mar 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986256	Drug: BMS-986256; Specified dose on specified days; Drug: Milk of magnesia; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) of [14C] BMS-986256 [Up to 49 days]

2. Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256 [Up to 49 days]

3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256 [Up to 49 days]

Secondary Outcome Measures

1. Incidence of Adverse Events (AEs) [Up to 49 days]

2. Incidence of Serious Adverse Events (SAEs) [Up to 49 days]

3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 49 days]

4. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to 49 days]

5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 49 days]

6. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 49 days]

7. Incidence of clinically significant changes in vital signs: Heart rate [Up to 49 days]

8. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 49 days]

9. Incidence of clinically significant changes in vital signs: Body temperature [Up to 49 days]

10. Incidence of clinically significant changes in electrocardiogram (ECG) parameters [Up to 49 days]

11. Incidence of clinically significant changes in physical examination findings [Up to 49 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy participants, as determined by no clinically significant deviations from normal in medical history, physical examination abnormalities that would compromise the ability to participate, complete, and/or interpret the results of the study, 12-lead electrocardiograms (ECGs), vital signs, and clinical laboratory results.

• Males must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

• Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study

• History of any significant drug and/or food allergies

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance - Clinical Pharmacology Services - Madison	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04269356
• Other Study ID Numbers: IM026-023
• First Posted: Feb 13, 2020
• Last Update Posted: Jan 10, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Magnesium Oxide; Magnesium Hydroxide

Study Results

No Results Posted as of Jan 10, 2022