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A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 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: NCT05981963
Recruitment Status : Completed
First Posted : August 8, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: [14C]-BMS-986196 Phase 1

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: 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
Actual Study Start Date : August 17, 2023
Actual Primary Completion Date : October 22, 2023
Actual Study Completion Date : October 22, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: [14C]-BMS-986196 Drug: [14C]-BMS-986196
Specified dose on specified days
Other Name: BMS-986196


Outcome Measures
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Primary Outcome Measures :
  1. Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax) [ Time Frame: Up to Day 15 ]
  2. TRA: Time of Cmax (Tmax) [ Time Frame: Up to Day 15 ]
  3. TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) [ Time Frame: Up to Day 15 ]
  4. TRA: Amount of radioactivity recovered in urine (UR) [ Time Frame: Up to Day 15 ]
  5. TRA: Amount of radioactivity recovered in feces (FR) [ Time Frame: Up to Day 15 ]
  6. TRA: Amount of radioactivity recovered in bile (BR) [ Time Frame: Up to 14 hours post dose ]
  7. TRA: Percent of administered dose recovered in urine (%UR) [ Time Frame: Up to Day 15 ]
  8. TRA: Percent of administered dose recovered in feces (%FR) [ Time Frame: Up to Day 15 ]
  9. TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total) [ Time Frame: Up to Day 15 ]

Secondary Outcome Measures :
  1. Cmax [ Time Frame: Up to Day 15 ]
  2. Tmax [ Time Frame: Up to Day 15 ]
  3. AUC (0-T) [ Time Frame: Up to Day 15 ]
  4. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Day 29 ]
  5. Number of Participants with Serious AEs (SAEs) [ Time Frame: Up to Day 29 ]
  6. Number of Participants with AEs Leading to Discontinuation [ Time Frame: Up to Day 29 ]
  7. Number of Participants with Vital Sign Abnormalities [ Time Frame: Up to Day 15 ]
  8. Number of Participants with Electrocardiogram (ECG) Abnormalities [ Time Frame: Up to Day 15 ]
  9. Number of Participants with Physical Examination Abnormalities [ Time Frame: Up to Day 15 ]
  10. Number of Participants with Clinical Laboratory Abnormalities [ Time Frame: Up to Day 15 ]

Eligibility Criteria
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Information from the National Library of Medicine

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

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.

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): NCT05981963


Locations
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United States, Wisconsin
Labcorp Clinical Research Unit - Madison
Madison, Wisconsin, United States, 53704-2526
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: NCT05981963    
Other Study ID Numbers: IM038-1007
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Pharmacokinetics
BMS-986196
Healthy male volunteers
[14C]-BMS-986196
Total radioactivity