Healthy VolunteersPhase 1NCT05686096
A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435
A Phase 1 study testing MYK-224 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to determine the absorption, metabolism, excretion; and to evaluate the safety and tolerability of BMS-986435 in healthy male participants Participants will be admitted to the study site for 3 weeks. 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?
- MYK-224
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2023to 8 Apr 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
- Body mass index between 18 and 32 kg/m^2, inclusive, at screening. - Healthy male participants as determined by the investigator and sponsor.
- Adequate acoustic windows to enable accurate transthoracic echocardiogram (TTE) assessment of parameters of left ventricular (LV) systolic function by TTE.
- Documented left ventricular ejection fraction (LVEF) ≥ 60% at screening.
Who cannot join
- Any acute or chronic medical illness.
- History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration).
- Head injury in the last 2 years, intracranial tumor, or aneurysm. Note: Other protocol defined Inclusion/Exclusion criteria may 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, Open-label, Single Dose Study to Assess the Absorption, Metabolism, and Excretion of [14C]BMS-986435 in Healthy Male Participants
The purpose of this study is to determine the absorption, metabolism, excretion; and to evaluate the safety and tolerability of BMS-986435 in healthy male participants
Participants will be admitted to the study site for 3 weeks.
- Conditions
- Healthy Volunteers
- Being tested
- MYK-224
- Keywords
- Absorption, Metabolism, and Excretion (ADME), MYK-224
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYK-224Drug
Also called BMS-986435
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| MYK-224 | Experimental | Not described Receives: Drug: MYK-224 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to 45 days
Time to maximum observed concentration (Tmax)
Measured: Up to 45 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Measured: Up to 45 days
Secondary outcomes (6)
Metabolite profiling of BMS-986435 in plasma, urine, and feces
Measured: Up to 45 days
Number of participants with adverse events (AEs)
Measured: Up to 45 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 45 days
Number of participants with vital sign abnormalities
Measured: Up to 45 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 45 days
Number of participants with physical examination abnormalities
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start16 Jan 2023
- Primary completion8 Apr 2023
- Study completion8 Apr 2023
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 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
- 7 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
- NCT05686096
- Sponsor's protocol ID
- CV029-012
- Status last verified
- May 2023
- First submitted
- 6 Jan 2023
- Last updated
- 25 May 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/disclosure-commitment.htm
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single Dose Study to Assess the Absorption, Metabolism, and Excretion of [14C]BMS-986435 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05686096
- Acronym / sponsor ID
- CV029-012
- Conditions
- Healthy Volunteers
- Keywords
- Absorption, Metabolism, and Excretion (ADME), MYK-224
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 8 Apr 2023 (actual)
- Study completion
- 8 Apr 2023 (actual)
- First posted
- 17 Jan 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 determine the absorption, metabolism, excretion; and to evaluate the safety and tolerability of BMS-986435 in healthy male participants
Participants will be admitted to the study site for 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MYK-224 | Experimental | Drug: MYK-224 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index between 18 and 32 kg/m^2, inclusive, at screening. - Healthy male participants as determined by the investigator and sponsor.
- Adequate acoustic windows to enable accurate transthoracic echocardiogram (TTE) assessment of parameters of left ventricular (LV) systolic function by TTE.
- Documented left ventricular ejection fraction (LVEF) ≥ 60% at screening.
Key exclusion criteria (3 listed)
- Any acute or chronic medical illness.
- History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration).
- Head injury in the last 2 years, intracranial tumor, or aneurysm. Note: Other protocol defined Inclusion/Exclusion criteria may 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 |
|---|---|---|
| MYK-224Also: BMS-986435Specified dose on specified days | Drug | MYK-224 |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to 45 days
Time to maximum observed concentration (Tmax)
Time frame: Up to 45 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to 45 days
6 secondary outcomes
Metabolite profiling of BMS-986435 in plasma, urine, and feces
Time frame: Up to 45 days
Number of participants with adverse events (AEs)
Time frame: Up to 45 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 45 days
Number of participants with vital sign abnormalities
Time frame: Up to 45 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 45 days
Number of participants with physical examination abnormalities
Time frame: Up to 45 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 25 May 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/disclosure-commitment.htm
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Healthy Participants
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 MYK-224 in people with Healthy Volunteers, 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 25 May 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?
Maximum observed concentration (Cmax) (time frame: Up to 45 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 25 May 2023.