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HealthyPhase 1NCT06688045

A Study of the Effects of Itraconazole on the Plasma Levels of Nemtabrutinib (MK-1026-013)

A Phase 1 study testing Nemtabrutinib and Itraconazole in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to learn what happens to levels of nemtabrutinib in a 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 itraconazole. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Nemtabrutinib and Itraconazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
30 Oct 2023to 6 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 45 years
  • Men only
  • 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) of18 to 32 kg/m^2 (inclusive)

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

  • Labcorp Clinical Research Unit Inc. (Site 0001)

    Honolulu, Hawaii, 96813

Other trials in United States

About this study

Official title: A Study to Evaluate the Effects of Multiple Oral Doses of Itraconazole on the Single-dose Pharmacokinetics of Nemtabrutinib in Healthy Male Participants

The goal of this study is to learn what happens to levels of nemtabrutinib in a 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 itraconazole.

Conditions
Healthy
Being tested
Nemtabrutinib, Itraconazole

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

  • ItraconazoleDrug

    Oral administration

Study groups in NCT06688045
Study groupRoleWhat they receive
Period 1: NemtabrutinibExperimentalParticipants receive a single oral dose of nemtabrutinib followed by a protocol specified wash-out period.
Receives: Drug: Nemtabrutinib
Period 2: Nemtabrutinib + ItraconazoleExperimentalParticipants receive oral doses of itraconazole once daily on Days 1 to 13 with a single oral dose of nemtabrutinib given with itraconazole on Day 4.
Receives: Drug: Nemtabrutinib; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 in plasma.

    Measured: At designated time points (up to approximately 10 days postdose)

  2. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Nemtabrutinib

    Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma.

    Measured: At designated time points (up to approximately 10 days postdose)

  3. Maximum Plasma Concentration (Cmax) of Nemtabrutinib

    Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma.

    Measured: At designated time points (up to approximately 10 days postdose)

  4. Time of Maximum Plasma Concentration (Tmax) of Nemtabrutinib

    Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma.

    Measured: At designated time points (up to approximately 10 days postdose)

  5. Apparent Terminal Half-life (t1/2) of Nemtabrutinib

    Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma.

    Measured: At designated time points (up to approximately 10 days postdose)

  6. Apparent Clearance (CL/F) of Nemtabrutinib

    Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma.

    Measured: At designated time points (up to approximately 10 days postdose)

  7. Apparent Volume of Distribution (Vz/F) of Nemtabrutinib

    Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma.

    Measured: At designated time points (up to approximately 10 days postdose)

Secondary outcomes (2)

  1. 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 6 weeks

  2. Number of Participants Who Discontinue from 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 experience an AE will be reported.

    Measured: Up to approximately 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2024
  2. Study start30 Oct 2023
  3. Primary completion6 Jan 2024
  4. Study completion6 Jan 2024

Resources

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06688045
Sponsor's protocol ID
1026-013
Other IDs
MK-1026-013
Status last verified
Oct 2024
First submitted
12 Nov 2024
Last updated
14 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nemtabrutinib and Itraconazole 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 14 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: At designated time points (up to approximately 10 days postdose)). The study lists 7 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 NCT06688045.

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 Nov 2024.

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