Drug Interaction Research Study with Opevesostat
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?
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
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 fasting conditions, followed by hormone replacement therapy under fed conditions
Washout
A washout period of at least 5 days between opevesostat dosing in Period 1 and the first carbamazepine dosing in Period 2
Opevesostat Period 2
Carbamazepine is administered twice daily for 17 days with a single dose of opevesostat on Day 14
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Opevesostat
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