Opevesostat Interaction Study
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Opevesostat Period 1
A single dose of opevesostat is administered under fed conditions, followed by steroid replacement approximately 4.5 hours later.
Washout
A washout period of at least 5 days between opevesostat dosing in Period 1 and the first itraconazole dosing in Period 2.
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events.
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
There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, itraconazole will be administered once daily (QD) for 9 consecutive days with a single dose of opevesostat coadministered on Day 4 under fed conditions. Steroid replacement (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 4 through 6, approximately 4.5 hours after opevesostat and/or itraconazole dosing.
On Day 1, a single dose of opevesostat will be administered under fed conditions. A single dose of steroid replacement (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after opevesostat dosing.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
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
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.
5.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov/41732008/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1REkjxVPOXnW9o1_RPH3NnGUvZDhMSNLtkoVFGx848QfU6O5W7&fc=20210722141531&ff=20260407225654&v=2.19.0.post6+133c1feSteroidogenesis 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 ...
7.
aacrjournals.org
aacrjournals.org/cancerres/article/85/8_Supplement_2/CT176/761812/Abstract-CT176-Pharmacokinetics-PK-of-the-novelPharmacokinetics (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.
8.
uclahealth.org
uclahealth.org/clinical-trials/substudy-01a-safety-and-efficacy-opevesostat-mk-5684-basedSubstudy 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.
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