14 Participants Needed

Drug Interaction Research Study with Opevesostat

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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?

Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer.The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to opevesostat in the body when it is given with and without another medicine called carbamazepine.

Do I need to stop my current medications for the trial?

Yes, you need to stop taking any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements, starting 14 days before the first dose.

What safety data exists for Opevesostat (MK-5684, ODM-208)?

The provided research does not specifically mention safety data for Opevesostat, MK-5684, or ODM-208. The studies focus on drug-drug interactions (DDIs) with oral antineoplastics and the sensitivity of databases in detecting these interactions. However, they do not provide specific safety data or evaluations for Opevesostat or its other names.12345

Is the drug Opevesostat a promising treatment?

The information provided does not directly address the effectiveness or promise of Opevesostat as a treatment. The articles focus on drug interactions, but do not mention Opevesostat specifically. Therefore, based on the given information, we cannot determine if Opevesostat is a promising treatment.16789

What data supports the idea that Drug Interaction Research Study with Opevesostat is an effective treatment?

The available research does not provide specific data on the effectiveness of Opevesostat as a treatment. Instead, it focuses on drug-drug interactions with oral anticancer drugs, including Opevesostat. These studies highlight the importance of understanding potential interactions when using such drugs, but they do not directly address the effectiveness of Opevesostat itself.1251011

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 males who haven't smoked or used nicotine products in the last 3 months. They must have a BMI between 18.0 and 32.0 kg/m2 and be able to swallow multiple tablets.

Inclusion Criteria

My BMI is between 18.0 and 32.0.
I can swallow several pills at once.
I haven't smoked or used nicotine products for at least 3 months.

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 fasting conditions, followed by hormone replacement therapy under fed conditions

1 day
1 visit (in-person)

Washout

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

5 days

Opevesostat Period 2

Carbamazepine is administered twice daily for 17 days with a single dose of opevesostat on Day 14

17 days
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Opevesostat
Trial Overview The study is testing opevesostat, a potential prostate cancer treatment, to see how it behaves in the body over time with and without carbamazepine, another medication.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Opevesostat Period 2Experimental Treatment4 Interventions
There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first carbamazepine dosing in Period 2. In Period 2, carbamazepine will be administered twice daily (BID) for 17 consecutive days with a single dose of opevesostat coadministered on the morning of Day 14 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions on Day 14, approximately 4.5 hours after opevesostat and/or carbamazepine dosing.
Group II: Opevesostat Period 1Experimental Treatment3 Interventions
On Day 1 a single dose of opevesostat will be administered under fasting conditions and a single dose of hormone replacement therapy (HRT) (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

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

Published Research Related to This Trial

A study analyzing pharmacy claims data from 2008 to 2010 found high rates of coprescription of drugs that could potentially interact with nine enzyme-targeted kinase inhibitors, with coprescribing rates ranging from 23% to 57% depending on the specific drug.
Patients who were coprescribed these interacting drugs often had more medications overall, indicating a complex treatment regimen that may require careful monitoring to avoid decreased effectiveness or increased toxicity of the cancer treatments.
Twelve-month frequency of drug-metabolizing enzyme and transporter-based drug-drug interaction potential in patients receiving oral enzyme-targeted kinase inhibitor antineoplastic agents.Bowlin, SJ., Xia, F., Wang, W., et al.[2021]
Lexi-Interact and Drugs.com demonstrated high sensitivity (95%) in detecting drug interactions with oral antineoplastics, while Epocrates had a sensitivity of 90%, and Micromedex and Facts & Comparisons were lower at 70%.
There is a significant variation in the effectiveness of different drug interaction databases, indicating that clinicians should use multiple resources and their clinical judgment rather than relying on a single database for assessing drug interactions in oncology.
Drug Interaction Database Sensitivity With Oral Antineoplastics: An Exploratory Analysis.Bossaer, JB., Thomas, CM.[2018]
In a study analyzing pharmacokinetic drug-drug interactions (DDIs) for 34 FDA-approved drugs in 2017, CYP3A inhibition and induction were the primary mechanisms behind most interactions, with transporters like OATP1B1/1B3 mediating about half of them.
Five new drugs were identified as sensitive substrates to interactions, and three drugs were strong inhibitors, highlighting a significant risk of DDIs, particularly in oncology and antiviral treatments where patients often take multiple medications.
Mechanisms and Clinical Significance of Pharmacokinetic-Based Drug-Drug Interactions with Drugs Approved by the U.S. Food and Drug Administration in 2017.Yu, J., Petrie, ID., Levy, RH., et al.[2019]

Citations

Twelve-month frequency of drug-metabolizing enzyme and transporter-based drug-drug interaction potential in patients receiving oral enzyme-targeted kinase inhibitor antineoplastic agents. [2021]
Drug Interaction Database Sensitivity With Oral Antineoplastics: An Exploratory Analysis. [2018]
Mechanisms and Clinical Significance of Pharmacokinetic-Based Drug-Drug Interactions with Drugs Approved by the U.S. Food and Drug Administration in 2017. [2019]
Sensitivity and specificity of drug interaction databases to detect interactions with recently approved oral antineoplastics. [2022]
Prevalence of potential drug-drug interactions in cancer patients treated with oral anticancer drugs. [2022]
Pharmacokinetic Drug-Drug Interactions with Drugs Approved by the US Food and Drug Administration in 2020: Mechanistic Understanding and Clinical Recommendations. [2023]
Literature based drug interaction prediction with clinical assessment using electronic medical records: novel myopathy associated drug interactions. [2021]
Drug Interactions With Oral Inhaled Medications. [2021]
Low risk of the TMPRSS2 inhibitor camostat mesylate and its metabolite GBPA to act as perpetrators of drug-drug interactions. [2022]
[Drug-drug interactions you should know!] [2019]
[Drug-drug interactions you should know!] [2019]
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