Healthy Male ParticipantsPhase 1NCT06088264
A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants
A Phase 1 study testing BMS-986322 in people with Healthy Male Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants. 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 Male Participants
- What is being tested?
- BMS-986322
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 22 Dec 2023
- 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
- Participants must have a body mass index of 18.0 to 32.0 kg/m2, inclusive.
- Participants will be required to always use a latex or other synthetic condom with spermicide during any sexual activity
- Participants must refrain from donating sperm during the entire study and for at least 90 days from dose of study drug.
Who cannot join
- Participant must not have had any clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months prior to admission to the clinic.
- Participant must not be currently employed in a job requiring radiation exposure monitoring.
- Participant must not have had any major surgery within 4 weeks of study drug administration that could impact upon the absorption of study drug
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986322 in Healthy Adult Male Participants
The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.
- Conditions
- Healthy Male Participants
- Being tested
- BMS-986322
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986322Drug
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Administration of BMS-986322 | Experimental | Not described Receives: Drug: BMS-986322 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed in plasma/whole blood concentration (Cmax)
Measured: Up to day 17
Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to day 17
Area under the plasma/whole blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to day 17
Time of maximum observed in plasma/whole blood concentration (T-max)
Measured: Up to day 17
Terminal elimination half-life (T-HALF)
Measured: Up to day 17
Apparent total body clearance (CL/F)
Measured: Up to day 17
Apparent volume of distribution of terminal phase (Vz/F)
Measured: Up to day 17
Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF))
Measured: Up to day 17
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)
Measured: Up to day 17
Total amount of radioactivity recovered in urine (UR)
Measured: Up to day 17
Percent of total amount of radioactivity recovered in urine (%UR)
Measured: Up to day 17
Total amount of radioactivity recovered in feces (FR)
Measured: Up to day 17
Percent of total amount of radioactivity recovered in feces (%FR)
Measured: Up to day 17
Total amount of radioactivity recovered in urine and feces combined (RTotal)
Measured: Up to day 17
Percent of total amount of radioactivity recovered in all excreta (%Total)
Measured: Up to day 17
Secondary outcomes (7)
Number of participants with adverse events (AEs)
Measured: Up to day 47
Number of participants with serious adverse events (SAEs)
Measured: Up to day 47
Number of participants with AEs leading to discontinuation
Measured: Up to day 47
Number of participants with vital sign abnormalities
Measured: Up to day 17
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to day 17
Number of participants with clinically significant physical examination findings
Measured: Up to day 17
Number of participants with clinical laboratory abnormalities
Measured: Up to day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start31 Oct 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male 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
- Non-randomised
- 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
- NCT06088264
- Sponsor's protocol ID
- IM032-1018
- Status last verified
- Mar 2024
- First submitted
- 12 Oct 2023
- Last updated
- 29 Mar 2024
- 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-andresearch/ disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. 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 Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986322 in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT06088264
- Acronym / sponsor ID
- IM032-1018
- Conditions
- Healthy Male Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 18 Oct 2023 (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 this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of BMS-986322 | Experimental | Drug: BMS-986322 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must have a body mass index of 18.0 to 32.0 kg/m2, inclusive.
- Participants will be required to always use a latex or other synthetic condom with spermicide during any sexual activity
- Participants must refrain from donating sperm during the entire study and for at least 90 days from dose of study drug.
Key exclusion criteria (3 listed)
- Participant must not have had any clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months prior to admission to the clinic.
- Participant must not be currently employed in a job requiring radiation exposure monitoring.
- Participant must not have had any major surgery within 4 weeks of study drug administration that could impact upon the absorption of study drug
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-986322Specified dose on specified days. | Drug | Administration of BMS-986322 |
Primary outcome
Maximum observed in plasma/whole blood concentration (Cmax)
Time frame: Up to day 17
Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to day 17
Area under the plasma/whole blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to day 17
Time of maximum observed in plasma/whole blood concentration (T-max)
Time frame: Up to day 17
Terminal elimination half-life (T-HALF)
Time frame: Up to day 17
Apparent total body clearance (CL/F)
Time frame: Up to day 17
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Up to day 17
Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF))
Time frame: Up to day 17
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)
Time frame: Up to day 17
Total amount of radioactivity recovered in urine (UR)
Time frame: Up to day 17
Percent of total amount of radioactivity recovered in urine (%UR)
Time frame: Up to day 17
Total amount of radioactivity recovered in feces (FR)
Time frame: Up to day 17
Percent of total amount of radioactivity recovered in feces (%FR)
Time frame: Up to day 17
Total amount of radioactivity recovered in urine and feces combined (RTotal)
Time frame: Up to day 17
Percent of total amount of radioactivity recovered in all excreta (%Total)
Time frame: Up to day 17
7 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to day 47
Number of participants with serious adverse events (SAEs)
Time frame: Up to day 47
Number of participants with AEs leading to discontinuation
Time frame: Up to day 47
Number of participants with vital sign abnormalities
Time frame: Up to day 17
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to day 17
Number of participants with clinically significant physical examination findings
Time frame: Up to day 17
Number of participants with clinical laboratory abnormalities
Time frame: Up to day 17
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 29 Mar 2024.
- BMS Clinical Trial InformationLink 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-andresearch/ disclosure-commitment.html
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Health Volunteers
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-986322 in people with Healthy Male 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 3 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 29 Mar 2024. 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?
Maximum observed in plasma/whole blood concentration (Cmax) (time frame: Up to day 17). The study lists 15 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 29 Mar 2024.