Healthy VolunteersPhase 1NCT05806359
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian 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 safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian 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 Volunteers
- What is being tested?
- Danicamtiv
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2023to 14 Aug 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18 and 30 kilograms/meter squared inclusive, at the screening visit.
- Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese).
- Caucasian participants must be of European or Latin American Caucasian descent.
- A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol.
- Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception.
Who cannot join
- Any acute or chronic medical illness.
- Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator.
- History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- Note: Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Danicamtiv in Healthy Japanese and Caucasian Participants
The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.
- Conditions
- Healthy Volunteers
- Being tested
- Danicamtiv, Placebo
- Keywords
- Healthy, Danicamtiv, Japanese, Caucasian
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
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Japanese Cohort - Dose 1 | Experimental | Not described Receives: Drug: Danicamtiv; Drug: Placebo |
| Japanese Cohort - Dose 2 | Experimental | Not described Receives: Drug: Danicamtiv; Drug: Placebo |
| Japanese Cohort - Dose 3 | Experimental | Not described Receives: Drug: Danicamtiv; Drug: Placebo |
| Caucasian Cohort - Dose 3 | Experimental | Not described Receives: Drug: Danicamtiv; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Measured: Day 1 up to Day 28
Number of Participants with Vital Sign Abnormalities
Measured: Day 1 up to Day 7
Number of Participants with Electrocardiogram (ECG) Abnormalities
Measured: Day 1 up to Day 7
Number of Participants with Physical Examination Abnormalities
Measured: Day 1 up to Day 7
Number of Participants with Clinical Laboratory Abnormalities
Measured: Day 1 up to Day 7
Secondary outcomes (3)
Maximum Observed Plasma Concentration (Cmax)
Measured: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Time of Maximum Observed Plasma Concentration (Tmax)
Measured: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)]
Measured: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start31 Mar 2023
- Primary completion14 Aug 2023
- Study completion14 Aug 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 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
- NCT05806359
- Sponsor's protocol ID
- CV028-1001
- Status last verified
- May 2024
- First submitted
- 29 Mar 2023
- Last updated
- 23 May 2024
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Danicamtiv in Healthy Japanese and Caucasian Participants
- ClinicalTrials.gov ID
- NCT05806359
- Acronym / sponsor ID
- CV028-1001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy, Danicamtiv, Japanese, Caucasian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 10 Apr 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 safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Japanese Cohort - Dose 1 | Experimental | Drug: Danicamtiv, Drug: Placebo |
| Japanese Cohort - Dose 2 | Experimental | Drug: Danicamtiv, Drug: Placebo |
| Japanese Cohort - Dose 3 | Experimental | Drug: Danicamtiv, Drug: Placebo |
| Caucasian Cohort - Dose 3 | Experimental | Drug: Danicamtiv, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index between 18 and 30 kilograms/meter squared inclusive, at the screening visit.
- Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese).
- Caucasian participants must be of European or Latin American Caucasian descent.
- A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol.
- Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception.
Key exclusion criteria (4 listed)
- Any acute or chronic medical illness.
- Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator.
- History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- Note: 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 |
|---|---|---|
| DanicamtivAlso: BMS-986434, MYK-491Specified dose on specified days | Drug | Caucasian Cohort - Dose 3, Japanese Cohort - Dose 1, Japanese Cohort - Dose 2, Japanese Cohort - Dose 3 |
| PlaceboSpecified dose on specified days | Drug | Caucasian Cohort - Dose 3, Japanese Cohort - Dose 1, Japanese Cohort - Dose 2, Japanese Cohort - Dose 3 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Day 1 up to Day 28
Number of Participants with Vital Sign Abnormalities
Time frame: Day 1 up to Day 7
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time frame: Day 1 up to Day 7
Number of Participants with Physical Examination Abnormalities
Time frame: Day 1 up to Day 7
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Day 1 up to Day 7
3 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)]
Time frame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
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 23 May 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Screening Protocol
Pain
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 5 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 23 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?
Number of Participants with Adverse Events (AEs) (time frame: Day 1 up to Day 28). The study lists 5 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 23 May 2024.