HealthyPhase 1NCT06596668
Drug-Drug Interaction Study of Bomedemstat and Carbamazepine in Healthy Adult Participants (MK-3543-020)
A Phase 1 study testing bomedemstat and carbamazepine in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
Researchers have designed a study medicine called bomedemstat (MK-3543) as a new way to treat certain rare blood diseases. The purpose of this study is to learn what happens to bomedemstat in a person's body over time (a pharmacokinetic or PK study). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- bomedemstat and carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to 11 Mar 2025
- 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
- The main inclusion criteria include but are not limited to the following:
- Non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months before entering the study.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
- Medically healthy with no clinically significant medical history
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- History or presence of any of the following:
- Seizures
- Negative reactions in the blood system to any drugs
- Depression, unusual changes in mood or behavior or suicidal thoughts or behavior
- History of cancer
- Regular user of cannabis products within 6 months before entering the study.
- Unable to stop using or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days before entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Phase 1 Study to Characterize the Effects of a Strong Cytochrome P450 3A4 Inducer on the Pharmacokinetics of Bomedemstat in Healthy Adult Participants
Researchers have designed a study medicine called bomedemstat (MK-3543) as a new way to treat certain rare blood diseases.
The purpose of this study is to learn what happens to bomedemstat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to bomedemstat in the body when it is given alone and after multiple doses of another medicine called carbamazepine (CBZ).
- Conditions
- Healthy
- Being tested
- bomedemstat, carbamazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bomedemstatDrug
Also called MK-3543
Oral tablet
carbamazepineDrug
Oral extended-release capsule
| Study group | Role | What they receive |
|---|---|---|
| Bomedemstat + Carbamazepine | Experimental | A single dose of bomedemstat will be administered On Day 1 of Period 1. There will be a washout of 7 days between bomedemstat dosing in Period 1 and the first carbamazepine (CBZ) dose in Period 2. In Period 2, CBZ will be administered twice daily (BID) for 17 consecutive days, with a single dose of bomedemstat coadministered with the morning dose on Day 14. Receives: Drug: bomedemstat; Drug: carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of bomedemstat
AUC0-inf for bomedemstat in plasma will be determined
Measured: Predose and at designated timepoints up to 168 hours postdose
Secondary outcomes (10)
Number of participants who experience one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 66 days
Number of participants who discontinue study treatment due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 25 days
Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of bomedemstat
AUC0-last for bomedemstat in plasma will be determined
Measured: Predose and at designated timepoints up to 168 hours postdose
Area under the concentration versus time curve from 0 to 24 hours after dosing (AUC0-24) of bomedemstat
AUC0-24 for bomedemstat in plasma will be determined
Measured: Predose and at designated timepoints up to 24 hours postdose
Maximum observed concentration (Cmax) of bomedemstat
Cmax for bomedemstat in plasma will be determined
Measured: Predose and at designated timepoints up to 168 hours postdose
Maximum observed concentration 24 hours after dosing (C24) bomedemstat
Cmax for bomedemstat in plasma will be determined
Measured: Predose and at designated timepoints up to 24 hours postdose
Time to maximum concentration (Tmax) of bomedemstat
Tmax for bomedemstat in plasma will be determined
Measured: Predose and at designated timepoints up to 168 hours postdose
Apparent terminal half-life (t1/2) of bomedemstat
t1/2 for bomedemstat in plasma will be determined
Measured: Predose and at designated timepoints up to 168 hours postdose
Apparent clearance (CL/F) of bomedemstat
CL/F for bomedemstat in plasma will be determined
Measured: Predose and at designated timepoints up to 168 hours postdose
Apparent volume of distribution during terminal phase (Vz/F) of bomedemstat in plasma
Vz/F for bomedemstat in plasma will be determined
Measured: Predose and at designated timepoints up to 168 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Oct 2024
- Primary completion5 Feb 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596668
- Sponsor's protocol ID
- 3543-020
- Other IDs
- MK-3543-020
- Status last verified
- Mar 2025
- First submitted
- 11 Sep 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1 Study to Characterize the Effects of a Strong Cytochrome P450 3A4 Inducer on the Pharmacokinetics of Bomedemstat in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06596668
- Acronym / sponsor ID
- 3543-020
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 19 Sep 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.
Researchers have designed a study medicine called bomedemstat (MK-3543) as a new way to treat certain rare blood diseases.
The purpose of this study is to learn what happens to bomedemstat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to bomedemstat in the body when it is given alone and after multiple doses of another medicine called carbamazepine (CBZ).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bomedemstat + Carbamazepine | Experimental | Drug: bomedemstat, Drug: carbamazepineA single dose of bomedemstat will be administered On Day 1 of Period 1. There will be a washout of 7 days between bomedemstat dosing in Period 1 and the first carbamazepine (CBZ) dose in Period 2. In Period 2, CBZ will be administered twice daily (BID) for 17 consecutive days, with a single dose of bomedemstat coadministered with the morning dose on Day 14. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months before entering the study.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
- Medically healthy with no clinically significant medical history
Key exclusion criteria (8 listed)
- History or presence of any of the following:
- History of cancer
- Regular user of cannabis products within 6 months before entering the study.
- Unable to stop using or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days before entering the study.
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 |
|---|---|---|
| bomedemstatAlso: MK-3543Oral tablet | Drug | Bomedemstat + Carbamazepine |
| carbamazepineOral extended-release capsule | Drug | Bomedemstat + Carbamazepine |
Primary outcome
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of bomedemstat
Time frame: Predose and at designated timepoints up to 168 hours postdose
AUC0-inf for bomedemstat in plasma will be determined
10 secondary outcomes
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to approximately 66 days
Number of participants who discontinue study treatment due to an AE
Time frame: Up to approximately 25 days
Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of bomedemstat
Time frame: Predose and at designated timepoints up to 168 hours postdose
Area under the concentration versus time curve from 0 to 24 hours after dosing (AUC0-24) of bomedemstat
Time frame: Predose and at designated timepoints up to 24 hours postdose
Maximum observed concentration (Cmax) of bomedemstat
Time frame: Predose and at designated timepoints up to 168 hours postdose
Maximum observed concentration 24 hours after dosing (C24) bomedemstat
Time frame: Predose and at designated timepoints up to 24 hours postdose
Time to maximum concentration (Tmax) of bomedemstat
Time frame: Predose and at designated timepoints up to 168 hours postdose
Apparent terminal half-life (t1/2) of bomedemstat
Time frame: Predose and at designated timepoints up to 168 hours postdose
Apparent clearance (CL/F) of bomedemstat
Time frame: Predose and at designated timepoints up to 168 hours postdose
Apparent volume of distribution during terminal phase (Vz/F) of bomedemstat in plasma
Time frame: Predose and at designated timepoints up to 168 hours postdose
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 18 Mar 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
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 bomedemstat and carbamazepine in people with Healthy, run by Merck Sharp & Dohme LLC 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 8 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 18 Mar 2025. 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 concentration versus time curve from 0 to infinity (AUC0-inf) of bomedemstat (time frame: Predose and at designated timepoints up to 168 hours postdose). 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 18 Mar 2025.