Celerion ( Site 0001)
Tempe, Arizona, 85283, United States
NCT Number: NCT06633419
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.
Looking for future studies?
Notify Me18 year–55 year
Male
Interventional
Phase 1
Tempe, Arizona, 85283, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The main inclusion criteria include but are not limited to the following:
Exclusion criteria
The main exclusion criteria include but are not limited to the following:
Administered via oral tablet per dosing regimen.
Other names: MK-5684, ODM-208
Administered at a dose of 5 mg or 10 mg dependent on HRT dosing regimen via oral tablets.
Other names: RAYOS®, STERAPRED®, DELTASONE®
Administered at a dose of 0.05 mg or 0.1 mg dependent on HRT dosing regimen via oral tablets.
Other names: FLORINEF®
Administered at a dose of 100 mg, 200 mg, or 300 mg BID dependent on dosing regimen via oral capsule (extended-release).
Other names: TEGRETOL®
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
AUC0-inf of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
AUC0-last of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 24 hours post-dose
AUC0-24 of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
Cmax of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
Tmax of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
t1/2 of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
CL/F of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
Vz/F of opevesostat in plasma will be determined.
Time frame: Up to approximately 49 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be determined.
Time frame: Up to approximately 49 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue from the study due to an AE will be determined.
Merck Sharp & Dohme LLC
Industry
A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Carbamazepine on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details