A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male Participants

February 16, 2023 updated by: Bristol-Myers Squibb

A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C] BMS-986369 in Healthy Male Participants

The purpose of the study is to assess mass balance, biotransformation, and excretion of BMS-986369 following study drug administration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704-2526
        • Labcorp Clinical Research Unit - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male participants, of any race, determined by the investigator to have no significant deviation from normal in medical history or physical examination, which correspond to a condition that could potentially increase the risk for the participants, or jeopardize the integrity of the study data in 12-lead ECG measurements, vital signs, and clinical laboratory determinations at screening and/or check-in.
  • Body mass index (BMI) of 18.0 through 33.0 kilogram meter squared (kg/m^2), inclusive. BMI = weight kg/height m^2.
  • Absolute neutrophil counts must be greater than 2,500 per microliter (μL) at screening and Day -1.

Exclusion Criteria:

  • Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study.
  • Current or recent (within 3 months of study intervention administration) history of clinically significant endocrine, GI, cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities/diseases.
  • Participant has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion (ADME) (eg, bariatric procedure). Appendectomy, cholecystectomy, and uncomplicated hernia repair are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.

Prior/Concomitant Therapy

  • Participant has participated in another investigational trial within 4 weeks prior to screening. For participants who have participated in an investigational trial where no trial drug was administered or invasive procedure performed, the waiting interval may be eliminated.
  • Participant has received a vaccination, including coronavirus disease 2019 (COVID-19) vaccine, within 30 days prior to the IP dose or plans to receive vaccination within 2 months after dosing.
  • Participant has used a prescribed systemic or topical medication (eg, analgesics, anesthetics, anti-coagulants, etc.) within 30 days prior to the first dose administration. Exceptions may be made on a case-by-case basis if considered not to interfere with study objectives as agreed to by the investigator and Sponsor's Medical Monitor.
  • Use of CYP3A inducers (eg, St. John's wort) and inhibitors (eg, grapefruit juice) within 30 days prior to dosing.
  • Participant has used any non-prescribed systemic or topical medications (for example, vitamin/mineral supplements, and herbal medicines) within 14 days prior to the first dose administration. Exceptions may be made on a case-by-case basis if considered not to interfere with study objectives as agreed to by the investigator and Sponsor's Medical Monitor (eg, occasional use of acetaminophen).
  • Participant has received immunization with a live or live-attenuated vaccine within 2 months prior to dosing or is planning to receive immunization with a live or non-live vaccine for 2 months following dosing.
  • Participated in a radiolabeled drug study, where exposures are known to the investigator, within the previous 4 months prior to check-in (Day -1); or participated in a radiolabeled drug study, where exposures are not known to the investigator, within the previous 6 months prior to check-in (Day -1). The total 12-month exposure from this study and a maximum of 2 other previous studies within 4 to 12 months of this study will be within the CFR-recommended levels considered safe, per US Title 21 CFR 361.15: less than 5,000 mrem whole body annual exposure, with consideration given to the half-lives of the previous radiolabeled study drugs received.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BMS-986369
Drug: BMS-986369
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Total radioactivity recovered in whole blood
Time Frame: Up to 22 days
Up to 22 days
Total radioactivity recovered in plasma
Time Frame: Up to 22 days
Up to 22 days
Total radioactivity recovered in urine
Time Frame: Up to 22 days
Up to 22 days
Total radioactivity recovered in feces
Time Frame: Up to 22 days
Up to 22 days
Total radioactivity recovered in vomit
Time Frame: Up to 22 days
Up to 22 days
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 22 days
Up to 22 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Time Frame: Up to 22 days
Up to 22 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time Frame: Up to 22 days
Up to 22 days
Total radioactivity recovered in whole blood to plasma ratio
Time Frame: Up to 22 days
Up to 22 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 28 days
Up to 28 days
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 28 days
Up to 28 days
Number of participants with vital sign abnormalities
Time Frame: Up to 28 days
Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 28 days
Up to 28 days
Number of participants with clinical laboratory test abnormalities
Time Frame: Up to 28 days
Up to 28 days
Number of participants with physical examination abnormalities
Time Frame: Up to 28 days
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA073-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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