HealthyPhase 1NCT06698016
A Study of the Effect of Efavirenz on the Plasma Levels of Nemtabrutinib (MK-1026-014)
A Phase 1 study testing Nemtabrutinib and Efavirenz 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 (MK-1026) in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called efavirenz. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nemtabrutinib and Efavirenz
- 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
- 25 Jul 2023to 30 Oct 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The key inclusion criteria include but are not limited to the following:
- Is in good health based on medical history, physical examination, vital sign (VS) measurements, electrocardiograms (ECGs) and laboratory safety tests performed before allocation
- Has a body mass index (BMI) > 18 kg/m2 and ≤ 32 kg/m^2
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal (GI), 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
Altasciences Clinical Kansas, Inc. (Site 0001)
Overland Park, Kansas, 66212
About this study
Official title: A Study to Evaluate the Effect of Multiple Oral Doses of Efavirenz on the Single-Dose Pharmacokinetics of Nemtabrutinib in Healthy Participants
The goal of the study is to learn what happens to levels of nemtabrutinib (MK-1026) in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called efavirenz.
- Conditions
- Healthy
- Being tested
- Nemtabrutinib, Efavirenz
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 administration
EfavirenzDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Nemtabrutinib | Experimental | Participants receive a single dose of nemtabrutinib followed by a protocol specified wash-out period. Receives: Drug: Nemtabrutinib |
| Period 2: Nemtabrutinib + Efavirenz | Experimental | Participants receive oral doses of efavirenz once daily on Days 1 to 24 with a single oral dose of nemtabrutinib given with efavirenz on Day 11. Receives: Drug: Nemtabrutinib; Drug: Efavirenz |
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 Nemtabrutinib
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib.
Measured: Predose and at designated time points (up to 2 weeks)
Secondary outcomes (8)
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Nemtabrutinib
Blood samples will be collected to determine the AUC0-24hr of nemtabrutinib.
Measured: Predose and at designated time points (up to 24 hours postdose)
Maximum Plasma Concentration (Cmax) of Nemtabrutinib
Blood samples will be collected to determine the Cmax of nemtabrutinib.
Measured: Predose and at designated time points (up to 2 weeks)
Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib
Blood samples will be collected to determine the Tmax of nemtabrutinib.
Measured: Predose and at designated time points (up to 2 weeks postdose)
Apparent Clearance (CL/F) of Nembrutinib
Blood samples will be collected to determine the CL/F of nemtabrutinib.
Measured: Predose and at designated time points (up to 2 weeks)
Apparent Volume of Distribution During Terminal Phase (Vz/F) Nemtabrutinib
Blood samples will be collected to determine the Vz/F of nemtabrutinib.
Measured: Predose and at designated time points (up to 2 weeks)
Apparent Terminal Half-life (t1/2) of Nemtabrutinib
Blood samples will be collected to determine the t1/2 of nemtabrutinib.
Measured: Predose and at designated time points (up to 2 weeks)
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 study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Measured: Up to approximately 2 months
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. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start25 Jul 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
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
- Non-randomised
- Intervention model
- Sequential
- 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 Sharpe & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698016
- Sponsor's protocol ID
- 1026-014
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Multiple Oral Doses of Efavirenz on the Single-Dose Pharmacokinetics of Nemtabrutinib in Healthy Participants
- ClinicalTrials.gov ID
- NCT06698016
- Acronym / sponsor ID
- 1026-014
- 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
- 25 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 20 Nov 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 nemtabrutinib (MK-1026) in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called efavirenz.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: Nemtabrutinib | Experimental | Drug: NemtabrutinibParticipants receive a single dose of nemtabrutinib followed by a protocol specified wash-out period. |
| Period 2: Nemtabrutinib + Efavirenz | Experimental | Drug: Nemtabrutinib, Drug: EfavirenzParticipants receive oral doses of efavirenz once daily on Days 1 to 24 with a single oral dose of nemtabrutinib given with efavirenz on Day 11. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health based on medical history, physical examination, vital sign (VS) measurements, electrocardiograms (ECGs) and laboratory safety tests performed before allocation
- Has a body mass index (BMI) > 18 kg/m2 and ≤ 32 kg/m^2
Key exclusion criteria (3 listed)
- Has a history of clinically significant endocrine, gastrointestinal (GI), 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 administration | Drug | Period 1: Nemtabrutinib, Period 2: Nemtabrutinib + Efavirenz |
| EfavirenzOral administration | Drug | Period 2: Nemtabrutinib + Efavirenz |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
Time frame: Predose and at designated time points (up to 2 weeks)
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib.
8 secondary outcomes
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Nemtabrutinib
Time frame: Predose and at designated time points (up to 24 hours postdose)
Maximum Plasma Concentration (Cmax) of Nemtabrutinib
Time frame: Predose and at designated time points (up to 2 weeks)
Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib
Time frame: Predose and at designated time points (up to 2 weeks postdose)
Apparent Clearance (CL/F) of Nembrutinib
Time frame: Predose and at designated time points (up to 2 weeks)
Apparent Volume of Distribution During Terminal Phase (Vz/F) Nemtabrutinib
Time frame: Predose and at designated time points (up to 2 weeks)
Apparent Terminal Half-life (t1/2) of Nemtabrutinib
Time frame: Predose and at designated time points (up to 2 weeks)
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 2 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 2 months
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 20 Nov 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 Sharpe & 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 and Efavirenz 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 3 inclusion and 3 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 20 Nov 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 Nemtabrutinib (time frame: Predose and at designated time points (up to 2 weeks)). 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 20 Nov 2024.