Healthy ParticipantsPhase 1NCT05304533
A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants
A Phase 1 study testing MYK-224, Itraconazole and Verapamil 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 evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- MYK-224, Itraconazole and Verapamil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 29 Nov 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18 and 30 kg/m^2, inclusive
- Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine laboratory assessments
- Adequate acoustic windows to enable accurate transthoracic echocardiographic assessment
- Left Ventricular Ejection Fraction (LVEF) ≥60% at screening and ≥55% prior to MYK-224 dosing
Who cannot join
- Any acute or chronic medical illness
- History of dizziness and/or recurrent headaches
- History of heart disease
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, 3-Arm, Parallel Design Pharmacokinetic Interaction Study Between MYK-224 and Cytochrome P450 3A4 Inhibitors Itraconazole and Verapamil in Healthy Participants
The purpose of this study is to evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- MYK-224, Itraconazole, Verapamil
- Keywords
- MYK-224, Itraconazole, Verapamil
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
ItraconazoleDrug
Specified dose on specified days
VerapamilDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: MYK-224 | Experimental | Not described Receives: Drug: MYK-224 |
| Arm 2: MYK-224 + Itraconazole | Experimental | Not described Receives: Drug: MYK-224; Drug: Itraconazole |
| Arm 3: MYK-224 + Verapamil | Experimental | Not described Receives: Drug: MYK-224; Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to 36 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 36 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Measured: Up to 36 days
Secondary outcomes (15)
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 36 days
Apparent terminal plasma half-life (T-HALF)
Measured: Up to 36 days
Apparent total body clearance (CLT/F)
Measured: Up to 36 days
Number of participants with adverse events (AEs)
Measured: Up to 52 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 52 days
Number of participants with adverse events leading to discontinuation
Measured: Up to 52 days
Number of participants with vital sign abnormalities
Measured: Up to 52 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 52 days
Measurement of left ventricular ejection fraction (LVEF)
Measured: Up to 52 days
Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)
Measured: Up to 52 days
Measurement of left ventricular fractional shortening (LVFS)
Measured: Up to 52 days
Measurement of left ventricular global longitudinal strain (LV GLS)
Measured: Up to 52 days
Measurement of left ventricle stroke volume (LVSV)
Measured: Up to 52 days
Number of participants with physical exam abnormalities
Measured: Up to 52 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 52 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start21 Apr 2022
- Primary completion14 Nov 2022
- Study completion29 Nov 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT05304533
- Sponsor's protocol ID
- CV029-005
- Status last verified
- Jan 2023
- First submitted
- 22 Mar 2022
- Last updated
- 13 Jan 2023
- 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 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, 3-Arm, Parallel Design Pharmacokinetic Interaction Study Between MYK-224 and Cytochrome P450 3A4 Inhibitors Itraconazole and Verapamil in Healthy Participants
- ClinicalTrials.gov ID
- NCT05304533
- Acronym / sponsor ID
- CV029-005
- Conditions
- Healthy Participants
- Keywords
- MYK-224, Itraconazole, Verapamil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 31 Mar 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 this study is to evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: MYK-224 | Experimental | Drug: MYK-224 |
| Arm 2: MYK-224 + Itraconazole | Experimental | Drug: MYK-224, Drug: Itraconazole |
| Arm 3: MYK-224 + Verapamil | Experimental | Drug: MYK-224, Drug: Verapamil |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index between 18 and 30 kg/m^2, inclusive
- Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine laboratory assessments
- Adequate acoustic windows to enable accurate transthoracic echocardiographic assessment
- Left Ventricular Ejection Fraction (LVEF) ≥60% at screening and ≥55% prior to MYK-224 dosing
Key exclusion criteria (4 listed)
- Any acute or chronic medical illness
- History of dizziness and/or recurrent headaches
- History of heart disease
- 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 |
|---|---|---|
| MYK-224Also: BMS-986435Specified dose on specified days | Drug | Arm 1: MYK-224, Arm 2: MYK-224 + Itraconazole, Arm 3: MYK-224 + Verapamil |
| ItraconazoleSpecified dose on specified days | Drug | Arm 2: MYK-224 + Itraconazole |
| VerapamilSpecified dose on specified days | Drug | Arm 3: MYK-224 + Verapamil |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 36 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 36 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 36 days
15 secondary outcomes
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 36 days
Apparent terminal plasma half-life (T-HALF)
Time frame: Up to 36 days
Apparent total body clearance (CLT/F)
Time frame: Up to 36 days
Number of participants with adverse events (AEs)
Time frame: Up to 52 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 52 days
Number of participants with adverse events leading to discontinuation
Time frame: Up to 52 days
Number of participants with vital sign abnormalities
Time frame: Up to 52 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 52 days
Measurement of left ventricular ejection fraction (LVEF)
Time frame: Up to 52 days
Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)
Time frame: Up to 52 days
Measurement of left ventricular fractional shortening (LVFS)
Time frame: Up to 52 days
Measurement of left ventricular global longitudinal strain (LV GLS)
Time frame: Up to 52 days
Measurement of left ventricle stroke volume (LVSV)
Time frame: Up to 52 days
Number of participants with physical exam abnormalities
Time frame: Up to 52 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 52 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 13 Jan 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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 MYK-224, Itraconazole and Verapamil 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 4 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 Jan 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 plasma concentration (Cmax) (time frame: Up to 36 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 13 Jan 2023.