Healthy ParticipantsPhase 1NCT04269356
Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants
A Phase 1 study testing BMS-986256 and Milk of magnesia in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males. 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-986256 and Milk of magnesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 30 Mar 2021
- 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 participants, as determined by no clinically significant deviations from normal in medical history, physical examination abnormalities that would compromise the ability to participate, complete, and/or interpret the results of the study, 12-lead electrocardiograms (ECGs), vital signs, and clinical laboratory results.
- Males must agree to follow specific methods of contraception, if applicable, while participating in the trial
Who cannot join
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
- History of any significant drug and/or food allergies
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance - Clinical Pharmacology Services - Madison
Madison, Wisconsin, 53704
About this study
Official title: Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants
The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males.
Read the detailed description
Recruitment temporarily on hold due to COVID-19.
- Conditions
- Healthy Participants
- Being tested
- BMS-986256, Milk of magnesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986256Drug
Specified dose on specified days
Milk of magnesiaDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986256 | Experimental | Not described Receives: Drug: BMS-986256; Drug: Milk of magnesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of [14C] BMS-986256
Measured: Up to 49 days
Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256
Measured: Up to 49 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256
Measured: Up to 49 days
Secondary outcomes (11)
Incidence of Adverse Events (AEs)
Measured: Up to 49 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Measured: Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: Up to 49 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 49 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 49 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 49 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 49 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Measured: Up to 49 days
Incidence of clinically significant changes in physical examination findings
Measured: Up to 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start18 Feb 2020
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
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
- NCT04269356
- Sponsor's protocol ID
- IM026-023
- Status last verified
- Dec 2021
- First submitted
- 12 Feb 2020
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT04269356
- Acronym / sponsor ID
- IM026-023
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 13 Feb 2020 (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 assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males.
Detailed description
Recruitment temporarily on hold due to COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986256 | Experimental | Drug: BMS-986256, Drug: Milk of magnesia |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy participants, as determined by no clinically significant deviations from normal in medical history, physical examination abnormalities that would compromise the ability to participate, complete, and/or interpret the results of the study, 12-lead electrocardiograms (ECGs), vital signs, and clinical laboratory results.
- Males must agree to follow specific methods of contraception, if applicable, while participating in the trial
Key exclusion criteria (3 listed)
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
- History of any significant drug and/or food allergies
- Other protocol-defined inclusion/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 |
|---|---|---|
| BMS-986256Specified dose on specified days | Drug | BMS-986256 |
| Milk of magnesiaSpecified dose on specified days | Drug | BMS-986256 |
Primary outcome
Maximum observed plasma concentration (Cmax) of [14C] BMS-986256
Time frame: Up to 49 days
Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256
Time frame: Up to 49 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256
Time frame: Up to 49 days
11 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 49 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 49 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 49 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 49 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 49 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 49 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 49 days
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 49 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 10 Jan 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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-986256 and Milk of magnesia 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 2 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 10 Jan 2022. 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 plasma concentration (Cmax) of [14C] BMS-986256 (time frame: Up to 49 days). The study lists 3 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 10 Jan 2022.