HealthyPhase 1NCT06625827
A Study of the Effect of Nemtabrutinib (MK-1026) on the Plasma Levels of Digoxin in Healthy Participants (MK-1026-012)
A Phase 1 study testing Digoxin and Nemtabrutinib in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of the study is to learn what happens to levels of digoxin in a healthy person's body over time. Researchers will compare what happens to digoxin in the body when it is given with and without another medicine called nemtabrutinib. 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?
- Digoxin and Nemtabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 22 Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
- Has a body mass index (BMI) 18.0 to 32.0 kg/m^2 (inclusive)
Who cannot join
- Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
- Has a hypersensitivity to digoxin and/or to other digitalis preparations including inactive ingredients (eg, lactose, corn starch and potato starch)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effect of Nemtabrutinib on the Pharmacokinetics of Digoxin in Healthy Participants
The goal of the study is to learn what happens to levels of digoxin in a healthy person's body over time. Researchers will compare what happens to digoxin in the body when it is given with and without another medicine called nemtabrutinib. Researchers are testing if digoxin levels in the body are different when digoxin is given with or without nemtabrutinib.
- Conditions
- Healthy
- Being tested
- Digoxin, Nemtabrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigoxinDrug
Oral administration
NemtabrutinibDrug
Also called MK-1026, ARQ 531
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Digoxin | Experimental | Participants receive a single oral dose of digoxin (Treatment A). Receives: Drug: Digoxin |
| Digoxin + Nemtabrutinib | Experimental | Participants receive a single oral dose of digoxin coadministered with a single oral dose of nemtabrutinib (Treatment B). Receives: Drug: Digoxin; Drug: Nemtabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Digoxin
Blood samples will be collected to determine the AUC0-Inf of digoxin.
Measured: At designated timepoints (up to approximately 7 days)
Secondary outcomes (9)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Digoxin
Blood samples will be collected to determine the AUC0-Last of digoxin.
Measured: At designated timepoints (up to approximately 7 days)
Maximum Plasma Concentration (Cmax) of Digoxin
Blood samples will be collected to determine the Cmax of digoxin.
Measured: At designated timepoints (up to approximately 7 days)
Plasma Concentration 24 Hours Postdose (C24) of Digoxin
Blood samples will be collected to determine the C24 of digoxin.
Measured: At designated timepoints (up to approximately 24 hours)
Time to Maximum Plasma Concentration (Tmax) of Digoxin
Blood samples will be collected to determine the Tmax of digoxin.
Measured: Predose and at designated timepoints (up to approximately 7 days)
Apparent Terminal Half-life (t1/2) of Digoxin
Blood samples will be collected to determine t1/2 of digoxin.
Measured: At designated timepoints (up to approximately 7 days)
Apparent Clearance (CL/F) of Digoxin
Blood samples will be collected to determine the CL/F of digoxin.
Measured: At designated timepoints (up to approximately 7 days)
Apparent Volume of Distribution (Vz/F) of Digoxin
Blood samples will be collected to determine the Vz/F of digoxin.
Measured: At designated timepoints (up to approximately 7 days)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 8 weeks
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported.
Measured: Up to approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start7 Nov 2023
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06625827
- Sponsor's protocol ID
- 1026-012
- Other IDs
- MK-1026-012
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Nemtabrutinib on the Pharmacokinetics of Digoxin in Healthy Participants
- ClinicalTrials.gov ID
- NCT06625827
- Acronym / sponsor ID
- 1026-012
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 3 Oct 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 goal of the study is to learn what happens to levels of digoxin in a healthy person's body over time. Researchers will compare what happens to digoxin in the body when it is given with and without another medicine called nemtabrutinib. Researchers are testing if digoxin levels in the body are different when digoxin is given with or without nemtabrutinib.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digoxin | Experimental | Drug: DigoxinParticipants receive a single oral dose of digoxin (Treatment A). |
| Digoxin + Nemtabrutinib | Experimental | Drug: Digoxin, Drug: NemtabrutinibParticipants receive a single oral dose of digoxin coadministered with a single oral dose of nemtabrutinib (Treatment B). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
- Has a body mass index (BMI) 18.0 to 32.0 kg/m^2 (inclusive)
Key exclusion criteria (2 listed)
- Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
- Has a hypersensitivity to digoxin and/or to other digitalis preparations including inactive ingredients (eg, lactose, corn starch and potato starch)
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 |
|---|---|---|
| DigoxinOral administration | Drug | Digoxin, Digoxin + Nemtabrutinib |
| NemtabrutinibAlso: MK-1026, ARQ 531Oral administration | Drug | Digoxin + Nemtabrutinib |
Primary outcome
Area under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Digoxin
Time frame: At designated timepoints (up to approximately 7 days)
Blood samples will be collected to determine the AUC0-Inf of digoxin.
9 secondary outcomes
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Digoxin
Time frame: At designated timepoints (up to approximately 7 days)
Maximum Plasma Concentration (Cmax) of Digoxin
Time frame: At designated timepoints (up to approximately 7 days)
Plasma Concentration 24 Hours Postdose (C24) of Digoxin
Time frame: At designated timepoints (up to approximately 24 hours)
Time to Maximum Plasma Concentration (Tmax) of Digoxin
Time frame: Predose and at designated timepoints (up to approximately 7 days)
Apparent Terminal Half-life (t1/2) of Digoxin
Time frame: At designated timepoints (up to approximately 7 days)
Apparent Clearance (CL/F) of Digoxin
Time frame: At designated timepoints (up to approximately 7 days)
Apparent Volume of Distribution (Vz/F) of Digoxin
Time frame: At designated timepoints (up to approximately 7 days)
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 8 weeks
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 8 weeks
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 3 Oct 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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 Digoxin and Nemtabrutinib 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 2 inclusion and 2 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 3 Oct 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?
Area under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Digoxin (time frame: At designated timepoints (up to approximately 7 days)). 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 3 Oct 2024.