HealthyPhase 1NCT06772818
A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-017)
A Phase 1 study testing 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 nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions. 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?
- Nemtabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 16 Feb 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 history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer (malignancy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit Inc. (Site 0001)
Honolulu, Hawaii, 96813
About this study
Official title: A Study to Evaluate the Effect of Food on the Pharmacokinetics of the Nemtabrutinib Final Market Formulation 2 (FMF2) in Healthy Participants
The goal of the study is to learn what happens to levels of nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions.
- Conditions
- Healthy
- Being tested
- Nemtabrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemtabrutinibDrug
Also called MK-1026, ARQ-531
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Nemtabrutinib Treatment A | Experimental | Participants receive a single dose of nemtabrutinib on Day 1 under fasted conditions (on an empty stomach after a 10-hour overnight fast) Receives: Drug: Nemtabrutinib |
| Nemtabrutinib Treatment B | Experimental | Participants receive a single dose of nemtabrutinib on Day 1 under fed conditions (after a high-fat meal) Receives: 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 extrapolated to infinity (AUC0-inf) of Nemtabrutinib
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma.
Measured: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Secondary outcomes (9)
Time Taken for the Drug to Appear in the Systemic Circulation Following Administration (Tlag) of Nemtabrutinib
Blood samples will be collected to determine the Tlag of nemtabrutinib in plasma.
Measured: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Terminal Elimination Half-Life (t1/2) of Nemtabrutinib
Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma.
Measured: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib
Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma.
Measured: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Nemtabrutinib
Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma.
Measured: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Nemtabrutinib
Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma.
Measured: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Maximum Observed Concentration (Cmax) of Nemtabrutinib
Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma.
Measured: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib
Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma.
Measured: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Measured: Up to 30 days
Number of Participants Who Discontinue the Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start2 Oct 2023
- Primary completion20 Dec 2023
- Study completion16 Feb 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
- 20 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
- NCT06772818
- Sponsor's protocol ID
- 1026-017
- Other IDs
- MK-1026-17
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 14 Jan 2025
- 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Food on the Pharmacokinetics of the Nemtabrutinib Final Market Formulation 2 (FMF2) in Healthy Participants
- ClinicalTrials.gov ID
- NCT06772818
- Acronym / sponsor ID
- 1026-017
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 14 Jan 2025 (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 nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nemtabrutinib Treatment A | Experimental | Drug: NemtabrutinibParticipants receive a single dose of nemtabrutinib on Day 1 under fasted conditions (on an empty stomach after a 10-hour overnight fast) |
| Nemtabrutinib Treatment B | Experimental | Drug: NemtabrutinibParticipants receive a single dose of nemtabrutinib on Day 1 under fed conditions (after a high-fat meal) |
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 history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer (malignancy)
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 |
|---|---|---|
| NemtabrutinibAlso: MK-1026, ARQ-531Oral Tablet | Drug | Nemtabrutinib Treatment A, Nemtabrutinib Treatment B |
Primary outcome
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Nemtabrutinib
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma.
9 secondary outcomes
Time Taken for the Drug to Appear in the Systemic Circulation Following Administration (Tlag) of Nemtabrutinib
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Terminal Elimination Half-Life (t1/2) of Nemtabrutinib
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Nemtabrutinib
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Nemtabrutinib
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Maximum Observed Concentration (Cmax) of Nemtabrutinib
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to 30 days
Number of Participants Who Discontinue the Study Intervention Due to an AE
Time frame: Up to 14 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 14 Jan 2025.
- 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 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 14 Jan 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-time curve from time 0 extrapolated to infinity (AUC0-inf) of Nemtabrutinib (time frame: Predose and at designated timepoints (up to approximately 2 weeks 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 14 Jan 2025.