HealthyPhase 1NCT07435194
A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007)
A Phase 1 study testing MK-2828, Itraconazole and Midazolam in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The main goals of this study are: To learn what happens to one dose of MK-2828 in a healthy person's body over time when it is taken with itraconzole To learn what happens to one dose of midazolam in a healthy person's body over time when it is taken with MK-2828 Researchers want to learn if the levels of MK-2828 in… Read more about this study
- Who is it for?
- Ages 24 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-2828, Itraconazole and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to 17 Aug 2026
- 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 24 to 60 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:
- Participant is in good health
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- History of cancer (malignancy)
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortea CRU Madison ( Site 0001)
Madison, Wisconsin, 53704
About this study
Official title: A Two-Part Clinical Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-2828 (Part 1) and Multiple Doses of MK-2828 on the Single-Dose PK of Midazolam (Part 2) in Healthy Participants
The main goals of this study are:
- To learn what happens to one dose of MK-2828 in a healthy person's body over time when it is taken with itraconzole
- To learn what happens to one dose of midazolam in a healthy person's body over time when it is taken with MK-2828
Researchers want to learn if the levels of MK-2828 in the body are about the same when MK-2828 is taken with itraconazole as when it is taken alone. They also want to know if taking MK-2828 more than once affects how much midazolam is in the body after a single dose.
- Conditions
- Healthy
- Being tested
- MK-2828, Itraconazole, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2828Drug
Administered orally as capsule
ItraconazoleDrug
Administered orally as syrup
MidazolamDrug
Administered orally as syrup
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Itraconazole | Experimental | Participants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828. Receives: Drug: MK-2828; Drug: Itraconazole |
| Part 2: Midazolam | Experimental | Participants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam. Receives: Drug: MK-2828; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 (Itraconazole): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-2828
Blood samples will be collected at multiple time points to determine the AUC0-inf of MK-2828.
Measured: Predose and at designated timepoints up to approximately 288 hours (hrs) postdose
Part 1 (Itraconazole): Maximum Plasma Concentration (Cmax) of MK-2828
Blood samples will be collected at multiple time points to determine the Cmax of MK-2828.
Measured: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 2 (Midazolam): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-inf of Midazolam.
Measured: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Maximum Plasma Concentration (Cmax) of Midazolam
Blood samples will be collected at multiple time points to determine the Cmax of Midazolam.
Measured: Predose and at designated timepoints up to approximately 24hrs postdose
Secondary outcomes (18)
Part 1 (Itraconazole): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-2828
Blood samples will be collected at multiple time points to determine the AUC0-last of MK-2828.
Measured: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of MK-2828
Blood samples will be collected at multiple time points to determine the AUC0-24 of MK-2828.
Measured: Predose and at designated timepoints up to approximately 24 hrs postdose
Part 1 (Itraconazole): Time to Maximum Plasma Concentration (Tmax) of MK-2828
Blood samples will be collected at multiple time points to determine the Tmax of MK-2828.
Measured: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Apparent Terminal Half-life (t1/2) of MK-2828
Blood samples will be collected at multiple time points to determine the t1/2 of MK-2828.
Measured: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Apparent Clearance (CL/F) of MK-2828
Blood samples will be collected at multiple time points to determine the CL/F of MK-2828.
Measured: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Plasma Concentration at 24 Hours (C24) of MK-2828
Blood samples will be collected at multiple time points to determine the C24 of MK-2828.
Measured: 24 hours postdose
Part 1 (Itraconazole): Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-2828
Blood samples will be collected at multiple time points to determine the Vz/F of MK-2828.
Measured: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Number of Participants Experiencing 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
Measured: Up to approximately 28 days
Part 1 (Itraconazole): 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported.
Measured: Up to approximately 23 days
Part 2 (Midazolam): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-last of Midazolam.
Measured: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-24 of Midazolam.
Measured: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Time to Maximum Plasma Concentration (Tmax) of Midazolam
Blood samples will be collected at multiple time points to determine the Tmax of Midazolam.
Measured: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Apparent Terminal Half-life (t1/2) of Midazolam
Blood samples will be collected at multiple time points to determine the t1/2 of Midazolam.
Measured: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Apparent Clearance (CL/F) of Midazolam
Blood samples will be collected at multiple time points to determine the CL/F of Midazolam.
Measured: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Plasma Concentration at 24 Hours (C24) of Midazolam
Blood samples will be collected at multiple time points to determine the C24 of Midazolam.
Measured: 24 hours postdose
Part 2 (Midazolam): Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam
Blood samples will be collected at multiple time points to determine the Vz/F of Midazolam.
Measured: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Number of Participants Experiencing 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
Measured: Up to approximately 23 days
Part 2 (Midazolam): 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported.
Measured: Up to approximately 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start6 Mar 2026
- Primary completion17 Aug 2026
- Study completion17 Aug 2026
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT07435194
- Sponsor's protocol ID
- 2828-007
- Other IDs
- MK-2828-007
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2026
- Last updated
- 8 Sep 2026
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Clinical Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-2828 (Part 1) and Multiple Doses of MK-2828 on the Single-Dose PK of Midazolam (Part 2) in Healthy Participants
- ClinicalTrials.gov ID
- NCT07435194
- Acronym / sponsor ID
- 2828-007
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 27 Feb 2026 (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 main goals of this study are:
- To learn what happens to one dose of MK-2828 in a healthy person's body over time when it is taken with itraconzole
- To learn what happens to one dose of midazolam in a healthy person's body over time when it is taken with MK-2828
Researchers want to learn if the levels of MK-2828 in the body are about the same when MK-2828 is taken with itraconazole as when it is taken alone. They also want to know if taking MK-2828 more than once affects how much midazolam is in the body after a single dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Itraconazole | Experimental | Drug: MK-2828, Drug: ItraconazoleParticipants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828. |
| Part 2: Midazolam | Experimental | Drug: MK-2828, Drug: MidazolamParticipants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam. |
Who may qualify
- Ages
- 24 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participant is in good health
Key exclusion criteria (3 listed)
- History of cancer (malignancy)
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
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 |
|---|---|---|
| MK-2828Administered orally as capsule | Drug | Part 1: Itraconazole, Part 2: Midazolam |
| ItraconazoleAdministered orally as syrup | Drug | Part 1: Itraconazole |
| MidazolamAdministered orally as syrup | Drug | Part 2: Midazolam |
Primary outcome
Part 1 (Itraconazole): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-2828
Time frame: Predose and at designated timepoints up to approximately 288 hours (hrs) postdose
Blood samples will be collected at multiple time points to determine the AUC0-inf of MK-2828.
Part 1 (Itraconazole): Maximum Plasma Concentration (Cmax) of MK-2828
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Blood samples will be collected at multiple time points to determine the Cmax of MK-2828.
Part 2 (Midazolam): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24hrs postdose
Blood samples will be collected at multiple time points to determine the AUC0-inf of Midazolam.
Part 2 (Midazolam): Maximum Plasma Concentration (Cmax) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24hrs postdose
Blood samples will be collected at multiple time points to determine the Cmax of Midazolam.
18 secondary outcomes
Part 1 (Itraconazole): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-2828
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of MK-2828
Time frame: Predose and at designated timepoints up to approximately 24 hrs postdose
Part 1 (Itraconazole): Time to Maximum Plasma Concentration (Tmax) of MK-2828
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Apparent Terminal Half-life (t1/2) of MK-2828
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Apparent Clearance (CL/F) of MK-2828
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Plasma Concentration at 24 Hours (C24) of MK-2828
Time frame: 24 hours postdose
Part 1 (Itraconazole): Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-2828
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to approximately 28 days
Part 1 (Itraconazole): Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 23 days
Part 2 (Midazolam): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Time to Maximum Plasma Concentration (Tmax) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Apparent Terminal Half-life (t1/2) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Apparent Clearance (CL/F) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Plasma Concentration at 24 Hours (C24) of Midazolam
Time frame: 24 hours postdose
Part 2 (Midazolam): Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): Number of Participants Experiencing an adverse event (AE)
Time frame: Up to approximately 23 days
Part 2 (Midazolam): Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 9 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 8 Sep 2026.
- 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 MK-2828, Itraconazole and Midazolam 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 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 8 Sep 2026. 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?
Part 1 (Itraconazole): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-2828 (time frame: Predose and at designated timepoints up to approximately 288 hours (hrs) postdose). The study lists 4 primary outcomes in all. 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 8 Sep 2026.