This trial is no longer recruiting.My employer runs this trial

Itraconazole and MK-2828 for Drug Interaction Study

TF
Overseen ByToll Free Number
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the body processes the drug MK-2828 when taken with itraconazole and how it interacts with midazolam. Researchers are testing whether the levels of MK-2828 change when combined with itraconazole compared to when taken alone. They also seek to determine if MK-2828 affects the level of midazolam in the body. The study seeks healthy individuals without a history of major diseases like cancer or serious heart and liver problems. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that itraconazole is usually well-tolerated by patients. Common side effects include nausea, vomiting, and dizziness, similar to other itraconazole products. However, itraconazole can interact with many other medications, so caution is necessary when taking other drugs.

Midazolam, another treatment in the study, is generally safe but can cause relaxation or sleepiness. Some serious side effects, such as breathing problems, have been reported, especially when combined with other medications.

MK-2828 is a new treatment, so less information is available about its safety. This study is in its early stages and primarily aims to understand how the body processes this drug. Researchers are still collecting safety data, so caution is advised.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore potential drug interactions between Itraconazole, Midazolam, and MK-2828. Itraconazole is a well-known antifungal medication, but in this context, it’s being used to study how it interacts with MK-2828, potentially influencing its metabolism or effectiveness. Midazolam, a sedative, is also being paired with MK-2828 to observe similar interactions. By understanding these interactions, researchers hope to uncover new ways to optimize the use of MK-2828, potentially enhancing its therapeutic benefits or reducing side effects when used alongside other medications.

What evidence suggests that this trial's treatments could be effective?

This trial will study the interactions between Itraconazole and MK-2828, as well as between Midazolam and MK-2828. Research has shown that itraconazole can alter the effects of other drugs by strongly inhibiting a liver enzyme called CYP3A, which helps break down drugs. Studies have found that itraconazole can significantly raise the levels of other drugs, like dordaviprone, in the body. In this trial, participants in one arm will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828.

For midazolam, research has found that taking it with drugs affecting liver enzymes can increase its concentration in the blood. This suggests that when midazolam is used with drugs like MK-2828, it could alter the drug's retention in the body. Participants in another arm of this trial will receive multiple oral doses of MK-2828 with a single oral dose of midazolam. These interactions are important because they can affect the medications' efficacy and safety.15678

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults with no significant medical issues. People who are not in good health or have certain conditions cannot participate.

Inclusion Criteria

\- Participant is in good health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Itraconazole Treatment

Participants receive multiple oral doses of Itraconazole with a single oral dose of MK-2828

Approximately 12 days
Multiple visits for blood sampling

Part 2: Midazolam Treatment

Participants receive multiple oral doses of MK-2828 with a single oral dose of midazolam

Approximately 9 days
Multiple visits for blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Itraconazole
  • Midazolam
  • MK-2828

Trial Overview

The study tests how the drug MK-2828 interacts with itraconazole and midazolam in healthy people. It looks at how these drugs affect each other's levels in the body after single or repeated doses.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2: MidazolamExperimental Treatment2 Interventions
Group II: Part 1: ItraconazoleExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40066762/

Drug-drug interaction study with itraconazole ...

This study aims to evaluate effect of CYP3A inhibition (using itraconazole) on venglustat exposure and to develop and validate a physiologically based ...

Itraconazole and MK-2828 for Drug Interaction Study

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.

NCT05154136 | A Drug-Drug Interaction Study to Evaluate ...

A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult Participants.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40289283/

A phase 1, randomized, crossover trial to assess the effect ...

Conclusion: Concomitant administration of dordaviprone with itraconazole significantly increased dordaviprone exposure confirming CYP3A4 is a ...

A Clinical Trial in Healthy Participants to Learn How ...

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 ...

Itraconazole: Precautions regarding drug interactions and ...

To describe patients with fungal infections in whom drug interactions and bioavailability problems were associated with itraconazole treatment failure.

SPORANOX® (itraconazole) Capsules - accessdata.fda.gov

Drug Interactions: • Coadministration of a number of CYP3A4 substrates are contraindicated with. SPORANOX®. Some examples of drugs that are contraindicated ...

Study Details | NCT07435194 | A Clinical Trial in Healthy ...

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 ...