Healthy VolunteersPhase 1NCT06027437
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
A Phase 1 study testing Danicamtiv 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 assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Danicamtiv
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2023to 10 Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive
- Participants with resting heart rate ≥ 55 bpm
- Seasonal allergies that do not require medication at the time of the study are acceptable
Who cannot join
- Any acute or chronic medical illness
- Head injury, intracranial tumor, or aneurysm within 2 years prior to screening
- History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Single-dose, 3-Period, 3-Sequence Crossover Study to Assess the Relative Bioavailability of the Intended Commercial Formulation Versus the Previous MyoKardia Formulation of Danicamtiv and to Assess the Effect of Food on the Pharmacokinetics of the Intended Commercial Formulation in Healthy Adult Participants
The purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.
- Conditions
- Healthy Volunteers
- Being tested
- Danicamtiv
- Keywords
- BMS-986434, MYK-491, Healthy, Biological Availability, Food Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanicamtivDrug
Also called BMS-986434, MYK-491
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: Danicamtiv |
| Treatment B | Experimental | Not described Receives: Drug: Danicamtiv |
| Treatment C | Experimental | Not described Receives: Drug: Danicamtiv |
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 day 16
Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to day 16
Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Measured: Up to day 16
Secondary outcomes (10)
Time of maximum observed plasma concentration (Tmax)
Measured: Up to day 16
Terminal elimination half-life (T-HALF)
Measured: Up to day 16
Apparent total body clearance (CLT/F)
Measured: Up to day 16
Apparent volume of distribution (Vz/F)
Measured: Up to day 16
Number of participants with Adverse Events (AEs)
Measured: Up to day 43
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to day 43
Number of participants with vital sign abnormalities
Measured: Up to day 16
Number of participants with Electrocardiogram (ECG) abnormalities
Measured: Up to day 16
Number of participants with Physical Examination (PE) abnormalities
Measured: Up to day 16
Number of participants with clinical laboratory abnormalities
Measured: Up to day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start5 Sep 2023
- Primary completion10 Nov 2023
- Study completion10 Nov 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT06027437
- Sponsor's protocol ID
- CV028-1012
- Status last verified
- Nov 2023
- First submitted
- 31 Aug 2023
- Last updated
- 29 Nov 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Single-dose, 3-Period, 3-Sequence Crossover Study to Assess the Relative Bioavailability of the Intended Commercial Formulation Versus the Previous MyoKardia Formulation of Danicamtiv and to Assess the Effect of Food on the Pharmacokinetics of the Intended Commercial Formulation in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06027437
- Acronym / sponsor ID
- CV028-1012
- Conditions
- Healthy Volunteers
- Keywords
- BMS-986434, MYK-491, Healthy, Biological Availability, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 7 Sep 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 assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Danicamtiv |
| Treatment B | Experimental | Drug: Danicamtiv |
| Treatment C | Experimental | Drug: Danicamtiv |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive
- Participants with resting heart rate ≥ 55 bpm
- Seasonal allergies that do not require medication at the time of the study are acceptable
Key exclusion criteria (3 listed)
- Any acute or chronic medical illness
- Head injury, intracranial tumor, or aneurysm within 2 years prior to screening
- History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion
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 |
|---|---|---|
| DanicamtivAlso: BMS-986434, MYK-491Specified dose on specified days. | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to day 16
Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to day 16
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 day 16
10 secondary outcomes
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to day 16
Terminal elimination half-life (T-HALF)
Time frame: Up to day 16
Apparent total body clearance (CLT/F)
Time frame: Up to day 16
Apparent volume of distribution (Vz/F)
Time frame: Up to day 16
Number of participants with Adverse Events (AEs)
Time frame: Up to day 43
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to day 43
Number of participants with vital sign abnormalities
Time frame: Up to day 16
Number of participants with Electrocardiogram (ECG) abnormalities
Time frame: Up to day 16
Number of participants with Physical Examination (PE) abnormalities
Time frame: Up to day 16
Number of participants with clinical laboratory abnormalities
Time frame: Up to day 16
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 Nov 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 Danicamtiv 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 29 Nov 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 day 16). 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 29 Nov 2023.