Opevesostat Interaction Study
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 itraconazole.
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
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
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
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