Healthy ParticipantsPhase 1NCT05320094
A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
A Phase 1 study testing Mavacamten and Activated Charcoal with Sorbitol 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 effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Mavacamten and Activated Charcoal with Sorbitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2022to 11 Sep 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18 and 30 kg/m^2, inclusive, at the Screening Visit
- Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments
Who cannot join
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease
- History of sorbitol or fructose intolerance or inability to tolerate activated charcoal
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants
The purpose of this study is to evaluate the effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- Mavacamten, Activated Charcoal with Sorbitol
- Keywords
- Mavacamten, Sorbitol, Activated Charcoal
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavacamtenDrug
Specified dose on specified days
Activated Charcoal with SorbitolDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Mavacamten | Experimental | Not described Receives: Drug: Mavacamten |
| Mavacamten and activated charcoal with sorbitol - Dose A | Experimental | Not described Receives: Drug: Mavacamten; Drug: Activated Charcoal with Sorbitol |
| Mavacamten and activated charcoal with sorbitol - Dose B | Experimental | Not described Receives: Drug: Mavacamten; Drug: Activated Charcoal with Sorbitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Measured: Up to 2 months
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
Measured: Up to 2 months
Maximum observed plasma concentration (Cmax)
Measured: Up to 1 month
Secondary outcomes (9)
Number of participants with adverse events (AEs)
Measured: Up to 3 months
Number of participants with serious adverse events (SAEs)
Measured: Up to 3 months
Number of participants with vital sign abnormalities exceeding predefined thresholds
Measured: Up to 3 months
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 3 Months
Number of participants with physical exam abnormalities
Measured: Up to 3 months
Number of participants with clinical laboratory evaluation abnormalities
Measured: Up to 3 months
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 1 month
Apparent terminal plasma half-life (T-HALF)
Measured: Up to 2 months
Concentration at 24 hours (C24)
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start15 Apr 2022
- Primary completion11 Sep 2022
- Study completion11 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 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
- NCT05320094
- Sponsor's protocol ID
- CV027-043
- Status last verified
- Oct 2022
- First submitted
- 1 Apr 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Merali S, Chiang M, Sychterz C, Chao L, Simmons T, Xu Y, Zhao A, Attanasio M, Murthy B, Perera V. Effect of Activated Charcoal on Mavacamten Pharmacokinetics in Healthy Participants. Am J Cardiovasc Drugs. 2024 Jul;24(4):569-575. doi: 10.1007/s40256-024-00659-z. Epub 2024 Jun 26.
PubMed 38926266
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants
- ClinicalTrials.gov ID
- NCT05320094
- Acronym / sponsor ID
- CV027-043
- Conditions
- Healthy Participants
- Keywords
- Mavacamten, Sorbitol, Activated Charcoal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 11 Sep 2022 (actual)
- Study completion
- 11 Sep 2022 (actual)
- First posted
- 11 Apr 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 effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mavacamten | Experimental | Drug: Mavacamten |
| Mavacamten and activated charcoal with sorbitol - Dose A | Experimental | Drug: Mavacamten, Drug: Activated Charcoal with Sorbitol |
| Mavacamten and activated charcoal with sorbitol - Dose B | Experimental | Drug: Mavacamten, Drug: Activated Charcoal with Sorbitol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index between 18 and 30 kg/m^2, inclusive, at the Screening Visit
- Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments
Key exclusion criteria (4 listed)
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease
- History of sorbitol or fructose intolerance or inability to tolerate activated charcoal
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- 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 |
|---|---|---|
| MavacamtenSpecified dose on specified days | Drug | Mavacamten, Mavacamten and activated charcoal with sorbitol - Dose A, Mavacamten and activated charcoal with sorbitol - Dose B |
| Activated Charcoal with SorbitolSpecified dose on specified days | Drug | Mavacamten and activated charcoal with sorbitol - Dose A, Mavacamten and activated charcoal with sorbitol - Dose B |
Primary outcome
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Time frame: Up to 2 months
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 2 months
Maximum observed plasma concentration (Cmax)
Time frame: Up to 1 month
9 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 3 months
Number of participants with serious adverse events (SAEs)
Time frame: Up to 3 months
Number of participants with vital sign abnormalities exceeding predefined thresholds
Time frame: Up to 3 months
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 3 Months
Number of participants with physical exam abnormalities
Time frame: Up to 3 months
Number of participants with clinical laboratory evaluation abnormalities
Time frame: Up to 3 months
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 1 month
Apparent terminal plasma half-life (T-HALF)
Time frame: Up to 2 months
Concentration at 24 hours (C24)
Time frame: Up to 1 month
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 8 Nov 2022.
- Derived from this study: PubMed 38926266Merali S, Chiang M, Sychterz C, Chao L, Simmons T, Xu Y, Zhao A, Attanasio M, Murthy B, Perera V. Effect of Activated Charcoal on Mavacamten Pharmacokinetics in Healthy Participants. Am J Cardiovasc Drugs. 2024 Jul;24(4):569-575. doi: 10.1007/s40256-024-00659-z. Epub 2024 Jun 26.
- 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.
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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 Mavacamten and Activated Charcoal with Sorbitol 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 2 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 8 Nov 2022. 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?
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) (time frame: Up to 2 months). 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?
On the ClinicalTrials.gov record for NCT05320094, which also lists 1 linked publication.
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 8 Nov 2022.