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Drug Interaction Research Study with Opevesostat

Tempe, AZ

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Able to swallow multiple tablets

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose, and at designated timepoints up to 96 hours post-dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called opevesostat to treat prostate cancer. The study will look at how opevesostat is processed in the body over time and compare its effects

See full description

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones for drug interaction studies may include nausea, headaches, dizziness, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow several pills at once.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose, and at designated timepoints up to 96 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose, and at designated timepoints up to 96 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, and at designated timepoints up to 96 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apparent Clearance (CL/F) of opevesostat in plasma

Apparent terminal half-life (t1/2) of opevesostat in plasma

Apparent volume of distribution during terminal phase (Vz/F) of opevesostat in plasma

+5 more

Secondary study objectives

Number of participants who discontinue study intervention due to an AE

Number of participants who experience one or more adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Fludrocortisone acetate

2024

Completed Phase 1

~20