Healthy VolunteersPhase 1NCT06211179
A Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to Intact Oral 5 mg Mavacamten in Healthy Participants
A Phase 1 study testing Treatment A: Mavacamten intact oral capsule, Treatment B: Mavacamten open capsule in suspension and Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study to assess the relative bioavailability of 5 mg Mavacamten opened capsule administered via nasogastric tube compared to intact oral 5 mg Mavacamten in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Treatment A: Mavacamten intact oral capsule, Treatment B: Mavacamten open capsule in suspension and Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to 13 Jun 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must have a body mass index between 18 and 32 kg/m2.
- Participants must be healthy, as determined by physical examination, vital signs, ECGs, and clinical laboratory assessments.
- Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
Who cannot join
- Participants must not have any significant acute or chronic medical illness.
- Participants must not have any current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting.
- Participants must not be intolerant or allergic to lidocaine or cetacaine or any type of topical anesthetic.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single-dose, Three-way Crossover Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to 5 mg Mavacamten Intact Capsule in Healthy Participants
The purpose of this study to assess the relative bioavailability of 5 mg Mavacamten opened capsule administered via nasogastric tube compared to intact oral 5 mg Mavacamten in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Treatment A: Mavacamten intact oral capsule, Treatment B: Mavacamten open capsule in suspension, Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: Mavacamten intact oral capsuleDrug
Specified dose on specified days
Treatment B: Mavacamten open capsule in suspensionDrug
Specified dose on specified days
Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABC | Experimental | Not described Receives: Drug: Treatment A: Mavacamten intact oral capsule; Drug: Treatment B: Mavacamten open capsule in suspension; Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) |
| Sequence BCA | Experimental | Not described Receives: Drug: Treatment A: Mavacamten intact oral capsule; Drug: Treatment B: Mavacamten open capsule in suspension; Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) |
| Sequence CAB | Experimental | Not described Receives: Drug: Treatment A: Mavacamten intact oral capsule; Drug: Treatment B: Mavacamten open capsule in suspension; Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to 37 days
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T])
Measured: Up to 37 days
Area under the concentration-time curve from time 0 to 72 hours (AUC[0-72])
Measured: Up to 37 days
Area under the concentration-time curve from time 0 to infinite time (AUC[0-INF])
Measured: Up to 37 days
Secondary outcomes (10)
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 37 days
Terminal half-life (T-HALF)
Measured: Up to 37 days
Apparent clearance (CLT/F)
Measured: Up to 37 days
Apparent volume of distribution (Vz/F)
Measured: Up to 37 days
Number of participants with adverse events (AEs)
Measured: Up to 37 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 37 days
Number of participants with vital sign abnormalities
Measured: Up to 37 days
Number of participants with electrocardiogram (ECG) findings
Measured: Up to 37 days
Number of participants with physical examination findings
Measured: Up to 37 days
Number of participants with abnormalities in clinical laboratory evaluations
Measured: Up to 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start10 Jan 2024
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
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
- 34 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
- NCT06211179
- Sponsor's protocol ID
- CV027-1070
- Status last verified
- Sep 2024
- First submitted
- 18 Dec 2023
- Last updated
- 19 Sep 2024
- 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-andresearch/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, Three-way Crossover Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to 5 mg Mavacamten Intact Capsule in Healthy Participants
- ClinicalTrials.gov ID
- NCT06211179
- Acronym / sponsor ID
- CV027-1070
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 18 Jan 2024 (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 to assess the relative bioavailability of 5 mg Mavacamten opened capsule administered via nasogastric tube compared to intact oral 5 mg Mavacamten in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence ABC | Experimental | Drug: Treatment A: Mavacamten intact oral capsule, Drug: Treatment B: Mavacamten open capsule in suspension, Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) |
| Sequence BCA | Experimental | Drug: Treatment A: Mavacamten intact oral capsule, Drug: Treatment B: Mavacamten open capsule in suspension, Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) |
| Sequence CAB | Experimental | Drug: Treatment A: Mavacamten intact oral capsule, Drug: Treatment B: Mavacamten open capsule in suspension, Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must have a body mass index between 18 and 32 kg/m2.
- Participants must be healthy, as determined by physical examination, vital signs, ECGs, and clinical laboratory assessments.
- Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
Key exclusion criteria (4 listed)
- Participants must not have any significant acute or chronic medical illness.
- Participants must not have any current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting.
- Participants must not be intolerant or allergic to lidocaine or cetacaine or any type of topical anesthetic.
- 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 |
|---|---|---|
| Treatment A: Mavacamten intact oral capsuleSpecified dose on specified days | Drug | Sequence ABC, Sequence BCA, Sequence CAB |
| Treatment B: Mavacamten open capsule in suspensionSpecified dose on specified days | Drug | Sequence ABC, Sequence BCA, Sequence CAB |
| Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)Specified dose on specified days | Drug | Sequence ABC, Sequence BCA, Sequence CAB |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to 37 days
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T])
Time frame: Up to 37 days
Area under the concentration-time curve from time 0 to 72 hours (AUC[0-72])
Time frame: Up to 37 days
Area under the concentration-time curve from time 0 to infinite time (AUC[0-INF])
Time frame: Up to 37 days
10 secondary outcomes
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 37 days
Terminal half-life (T-HALF)
Time frame: Up to 37 days
Apparent clearance (CLT/F)
Time frame: Up to 37 days
Apparent volume of distribution (Vz/F)
Time frame: Up to 37 days
Number of participants with adverse events (AEs)
Time frame: Up to 37 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 37 days
Number of participants with vital sign abnormalities
Time frame: Up to 37 days
Number of participants with electrocardiogram (ECG) findings
Time frame: Up to 37 days
Number of participants with physical examination findings
Time frame: Up to 37 days
Number of participants with abnormalities in clinical laboratory evaluations
Time frame: Up to 37 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 19 Sep 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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-andresearch/disclosure-commitment.html
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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 Treatment A: Mavacamten intact oral capsule, Treatment B: Mavacamten open capsule in suspension and Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) 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 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 19 Sep 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?
Maximum observed concentration (Cmax) (time frame: Up to 37 days). The study lists 4 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 19 Sep 2024.