Celerion ( Site 0001)
Tempe, Arizona, 85283, United States
NCT Number: NCT06554639
Researchers have designed a study medicine called MK-5684 as a new way to treat prostate cancer.
The purpose of this study is to learn what happens to MK-5684 in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to MK-5684 in the body when it is given with and without another medicine called diltiazem.
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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.
Administered at a dose of 2.5 mg or 5 mg dependent on HRT dosing regimen via oral tablets.
Administered at a dose of 0.05 mg per HRT dosing regimen via oral tablets.
Administered at a dose of 240 mg per dosing regimen via oral capsule (extended-release).
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
AUC0-inf of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
AUC0-last of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 24 hours post-dose
AUC0-24 of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
Cmax of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
Tmax of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
t1/2 of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
CL/F of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
Vz/F of MK-5684 in plasma will be determined.
Time frame: Up to approximately 39 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.
Time frame: Up to approximately 39 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.
Merck Sharp & Dohme LLC
Industry
A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Diltiazem 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.
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