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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269356
Recruitment Status : Completed
First Posted : February 13, 2020
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : February 18, 2020
Actual Primary Completion Date : March 30, 2021
Actual Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of [14C] BMS-986256 [ Time Frame: Up to 49 days ]
  2. Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256 [ Time Frame: 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 [ Time Frame: Up to 49 days ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 49 days ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 49 days ]
  3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 49 days ]
  4. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 49 days ]
  5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 49 days ]
  6. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 49 days ]
  7. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 49 days ]
  8. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 49 days ]
  9. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 49 days ]
  10. Incidence of clinically significant changes in electrocardiogram (ECG) parameters [ Time Frame: Up to 49 days ]
  11. Incidence of clinically significant changes in physical examination findings [ Time Frame: Up to 49 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269356


Locations
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United States, Wisconsin
Covance - Clinical Pharmacology Services - Madison
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04269356    
Other Study ID Numbers: IM026-023
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Magnesium Oxide
Magnesium Hydroxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents