Healthy VolunteersPhase 1NCT06227975
A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants
A Phase 1 study testing [14C]-BMS-986368 in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy 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 Volunteers
- What is being tested?
- [14C]-BMS-986368
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 3 Apr 2024
- 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 as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator.
- Body mass index of 18.0 to 35.0 kg/m2, inclusive. Body mass index = weight (kg)/(height[m])^2
Who cannot join
- History of hypokalemia.
- Any significant acute or chronic medical illness as determined by the investigator.
- Participant has a history of syncope in the year prior to Day 1.
- Other protocol-defined incusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
Madison, Wisconsin, 53704-2526
About this study
Official title: A Phase 1, Single-center, Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants
The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy male participants.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-BMS-986368
- Keywords
- ADME, Healthy male volunteers, Pharmacokinetics, BMS-986368, CC-97489
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-BMS-986368Drug
Also called CC-97489
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| [14C]-BMS-986368 | Experimental | Not described Receives: Drug: [14C]-BMS-986368 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to Day 15
Time of maximum observed concentration (Tmax)
Measured: Up to Day 15
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Measured: Up to Day 15
Total Radioactivity (TRA)
Measured: Up to Day 30
Secondary outcomes (7)
Number of participants with Adverse Events (AEs)
Measured: Up to Day 36
Number of participants with Serious AEs (SAEs)
Measured: Up to Day 36
Number of participants with AEs leading to discontinuation
Measured: Up to Day 36
Number of participants with vital sign abnormalities
Measured: Up to Day 30
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 30
Number of participants with physical examination abnormalities
Measured: Up to Day 30
Number of participants with clinical laboratory test abnormalities
Measured: Up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start2 Feb 2024
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Celgene
- 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
- NCT06227975
- Sponsor's protocol ID
- IM045-1003
- Status last verified
- May 2024
- First submitted
- 19 Jan 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 13 May 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 Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06227975
- Acronym / sponsor ID
- IM045-1003
- Conditions
- Healthy Volunteers
- Keywords
- ADME, Healthy male volunteers, Pharmacokinetics, BMS-986368, CC-97489
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 29 Jan 2024 (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 investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy 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 |
|---|---|---|
| [14C]-BMS-986368 | Experimental | Drug: [14C]-BMS-986368 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator.
- Body mass index of 18.0 to 35.0 kg/m2, inclusive. Body mass index = weight (kg)/(height[m])^2
Key exclusion criteria (4 listed)
- History of hypokalemia.
- Any significant acute or chronic medical illness as determined by the investigator.
- Participant has a history of syncope in the year prior to Day 1.
- Other protocol-defined incusion/exclusion criteria apply.
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 |
|---|---|---|
| [14C]-BMS-986368Also: CC-97489Specified dose on specified days | Drug | [14C]-BMS-986368 |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to Day 15
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 15
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 15
Total Radioactivity (TRA)
Time frame: Up to Day 30
7 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 36
Number of participants with Serious AEs (SAEs)
Time frame: Up to Day 36
Number of participants with AEs leading to discontinuation
Time frame: Up to Day 36
Number of participants with vital sign abnormalities
Time frame: Up to Day 30
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 30
Number of participants with physical examination abnormalities
Time frame: Up to Day 30
Number of participants with clinical laboratory test abnormalities
Time frame: Up to Day 30
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 13 May 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.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 [14C]-BMS-986368 in people with Healthy Volunteers, run by Celgene 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 2 inclusion and 4 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 13 May 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 concentration (Cmax) (time frame: Up to Day 15). The study lists 4 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 13 May 2024.