Prostatic Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGMK-5684
Administered via oral tablet per dosing regimen.
DRUGPrednisone
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.
DRUGDiltiazem hydrocholoride
Administered at a dose of 240 mg per dosing regimen via oral capsule (extended-release).
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting * Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2 * Able to swallow multiple tablets
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent volume of distribution during terminal phase (Vz/F) of MK-5684 in plasma | Predose, and at designated timepoints up to 120 hours post-dose | Vz/F of MK-5684 in plasma will be determined. |
| Apparent terminal half-life (t1/2) of MK-5684 in plasma | Predose, and at designated timepoints up to 120 hours post-dose | t1/2 of MK-5684 in plasma will be determined. |
| Apparent Clearance (CL/F) of MK-5684 in plasma | Predose, and at designated timepoints up to 120 hours post-dose | CL/F of MK-5684 in plasma will be determined. |
| Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma | Predose, and at designated timepoints up to 120 hours post-dose | AUC0-inf of MK-5684 in plasma will be determined. |
| Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-5684 in plasma | Predose, and at designated timepoints up to 120 hours post-dose | AUC0-last of MK-5684 in plasma will be determined. |
| Area under the concentration versus time curve from 0 to Hour 24 (AUC0-24) of MK-5684 in plasma | Predose, and at designated timepoints up to 24 hours post-dose | AUC0-24 of MK-5684 in plasma will be determined. |
| Maximum concentration (Cmax) of MK-5684 in plasma | Predose, and at designated timepoints up to 120 hours post-dose | Cmax of MK-5684 in plasma will be determined. |
| Time to Maximum concentration (Tmax) of MK-5684 in plasma | Predose, and at designated timepoints up to 120 hours post-dose | Tmax of MK-5684 in plasma will be determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who discontinue study intervention due to an AE | 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. |
| Number of participants who experience one or more adverse events (AEs) | 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. |
Countries
United States
Outcome results
None listed