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Opevesostat Interaction Study

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Age: 18 - 65
Sex: Male
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 tests a new medicine, opevesostat, for treating prostate cancer. Researchers aim to understand how opevesostat works in the body, both alone and in combination with itraconazole, an antifungal drug. The study consists of two parts: taking opevesostat alone and then with itraconazole after a short break. Individuals who are generally healthy and have no history of cancer or heart problems may be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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 or your doctor.

Is there any evidence suggesting that opevesostat is likely to be safe for humans?

Research shows that opevesostat is usually well-tolerated by patients. In earlier studies, this treatment blocked hormone production related to prostate cancer. Although all safety details are still under investigation, early results suggest that participants have not experienced serious side effects. It's important to remember that these findings come from early research stages, designed to assess how the treatment works in the body. Researchers closely monitor safety and side effects to ensure the treatment remains safe for future trials.12345

Why are researchers excited about this trial's treatments?

Opevesostat stands out because it introduces a new approach to treating conditions that require steroid replacement. Unlike standard steroid therapies, which often work independently, opevesostat is being studied for its potential to interact beneficially with steroid replacements and itraconazole, a common antifungal medication. Researchers are particularly excited about how opevesostat might enhance the effectiveness of these treatments, possibly leading to better outcomes with fewer side effects. This unique interaction could offer a more integrated and efficient treatment strategy for patients.

What evidence suggests that opevesostat might be an effective treatment for prostate cancer?

Studies have shown that opevesostat can effectively treat prostate cancer, particularly in advanced stages. Opevesostat blocks an enzyme called CYP11A1, crucial for hormone production. This is significant because it targets the hormones that promote prostate cancer growth. In previous research, patients with advanced prostate cancer responded well to opevesostat. This trial will explore how opevesostat interacts with other medications, such as itraconazole, prednisone, and fludrocortisone, to better understand its potential as a treatment option by inhibiting hormone production that fuels cancer.24678

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 adult men with no significant medical issues and a body mass index between 18.0 and 32.0. Participants should not have any major health problems.

Inclusion Criteria

I am medically healthy with no serious past health issues.
* Has a body mass index ≥18.0 and ≤32.0 kg/m\^2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Opevesostat Period 1

A single dose of opevesostat is administered under fed conditions, followed by steroid replacement approximately 4.5 hours later.

1 day
1 visit (in-person)

Washout

A washout period of at least 5 days between opevesostat dosing in Period 1 and the first itraconazole dosing in Period 2.

5 days

Opevesostat Period 2

Itraconazole is administered once daily for 9 consecutive days with a single dose of opevesostat coadministered on Day 4. Steroid replacement is administered on Days 4 through 6.

9 days
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events.

Up to approximately 28 days

What Are the Treatments Tested in This Trial?

Interventions

  • Fludrocortisone acetate
  • Itraconazole
  • Opevesostat
  • Prednisone

Trial Overview

The study tests how the new drug opevesostat moves through the body when taken alone or together with itraconazole, using prednisone and fludrocortisone acetate as supportive medications. Only healthy male volunteers are included.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Opevesostat Period 2Experimental Treatment4 Interventions
Group II: Opevesostat Period 1Experimental Treatment3 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

Steroidogenesis inhibitor opevesostat (MK-5684) for ... - PMC

The phase I/II CYPIDES trial demonstrates that opevesostat may be an effective treatment for patients with previously treated mCRPC, especially in those who ...

Pharmacokinetics (PK) of the novel nonsteroidal CYP11A1 ...

Results Among pts with mCRPC, midazolam PK were not altered by opevesostat. The AUCs had similar ratios between midazolam with opevesostat vs ...

NCT06136650 | A Study of Opevesostat (MK-5684) Versus ...

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone ...

Drug Interaction Research Study with Opevesostat

In trials, patients with advanced prostate cancer responded well to opevesostat. This drug blocks an enzyme called CYP11A1, crucial for hormone production.

Steroidogenesis inhibitor opevesostat (MK-5684) for ...

Results may support opevesostat as a potential new treatment option for mCRPC. ... Opevesostat is a drug that stops the body from producing all types of ...

1605P Opevesostat (MK-5684/ODM-208), an oral ...

Opevesostat is an oral, selective inhibitor of CYP11A1 that suppresses production of all steroid hormones and precursors. Initial phase 2 results in mCRPC ...

Pharmacokinetics (PK) of the novel nonsteroidal CYP11A1 ...

We present two such PK analyses: first, opevesostat's potential drug-drug interaction (DDI) with midazolam (a sensitive CYP3A4 substrate) in a dedicated cohort.

Substudy 01A: Safety and Efficacy of Opevesostat (MK- ...

The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.