Healthy ParticipantsPhase 1NCT05567510
A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male Participants
A Phase 1 study testing BMS-986369 in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of the study is to assess mass balance, biotransformation, and excretion of BMS-986369 following study drug administration. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986369
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2022to 27 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit - Madison
Madison, Wisconsin, 53704-2526
About this study
Official title: 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.
- Conditions
- Healthy Participants
- Being tested
- BMS-986369
- Keywords
- BMS-986369, Drug absorption, distribution, metabolism, and excretion (ADME)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986369Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986369 | Experimental | Not described Receives: Drug: BMS-986369 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity recovered in whole blood
Measured: Up to 22 days
Total radioactivity recovered in plasma
Measured: Up to 22 days
Total radioactivity recovered in urine
Measured: Up to 22 days
Total radioactivity recovered in feces
Measured: Up to 22 days
Total radioactivity recovered in vomit
Measured: Up to 22 days
Maximum observed plasma concentration (Cmax)
Measured: 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])
Measured: Up to 22 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Measured: Up to 22 days
Total radioactivity recovered in whole blood to plasma ratio
Measured: Up to 22 days
Secondary outcomes (6)
Number of participants with adverse events (AEs)
Measured: Up to 28 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 28 days
Number of participants with vital sign abnormalities
Measured: Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 28 days
Number of participants with clinical laboratory test abnormalities
Measured: Up to 28 days
Number of participants with physical examination abnormalities
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start20 Oct 2022
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567510
- Sponsor's protocol ID
- CA073-002
- Status last verified
- Feb 2023
- First submitted
- 3 Oct 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C] BMS-986369 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05567510
- Acronym / sponsor ID
- CA073-002
- Conditions
- Healthy Participants
- Keywords
- BMS-986369, Drug absorption, distribution, metabolism, and excretion (ADME)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess mass balance, biotransformation, and excretion of BMS-986369 following study drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986369 | Experimental | Drug: BMS-986369 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986369Specified dose on specified days | Drug | BMS-986369 |
Primary outcome
Total radioactivity recovered in whole blood
Time frame: Up to 22 days
Total radioactivity recovered in plasma
Time frame: Up to 22 days
Total radioactivity recovered in urine
Time frame: Up to 22 days
Total radioactivity recovered in feces
Time frame: Up to 22 days
Total radioactivity recovered in vomit
Time frame: Up to 22 days
Maximum observed plasma concentration (Cmax)
Time frame: 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
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 22 days
Total radioactivity recovered in whole blood to plasma ratio
Time frame: Up to 22 days
6 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 28 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 28 days
Number of participants with vital sign abnormalities
Time frame: Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 28 days
Number of participants with clinical laboratory test abnormalities
Time frame: Up to 28 days
Number of participants with physical examination abnormalities
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986369 in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radioactivity recovered in whole blood (time frame: Up to 22 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.