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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5684-011 | Other Identifier | MSD |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-5684 Period 1 | Experimental | On Day 1 a single dose of MK-5684 will be administered under fasting conditions and a single dose of HRT (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after MK-5684 dosing. |
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| MK-5684 Period 2 | Experimental | There will be a washout of at least 5 days between MK-5684 dosing in Period 1 and the first diltiazem dosing in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 6 consecutive days with a single dose of MK-5684 coadministered on Day 2 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 2 through 5, approximately 4.5 hours after MK-5684 and/or diltiazem dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-5684 | Drug | Administered via oral tablet per dosing regimen. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma | AUC0-inf of MK-5684 in plasma will be determined. | Predose, and at designated timepoints up to 120 hours post-dose |
| Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-5684 in plasma | AUC0-last of MK-5684 in plasma will be determined. | Predose, and at designated timepoints up to 120 hours post-dose |
| Area under the concentration versus time curve from 0 to Hour 24 (AUC0-24) of MK-5684 in plasma | AUC0-24 of MK-5684 in plasma will be determined. | Predose, and at designated timepoints up to 24 hours post-dose |
| Maximum concentration (Cmax) of MK-5684 in plasma | Cmax of MK-5684 in plasma will be determined. | Predose, and at designated timepoints up to 120 hours post-dose |
| Time to Maximum concentration (Tmax) of MK-5684 in plasma | Tmax of MK-5684 in plasma will be determined. | Predose, and at designated timepoints up to 120 hours post-dose |
| Apparent terminal half-life (t1/2) of MK-5684 in plasma | t1/2 of MK-5684 in plasma will be determined. | Predose, and at designated timepoints up to 120 hours post-dose |
| Apparent Clearance (CL/F) of MK-5684 in plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience one or more adverse events (AEs) | 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. | Up to approximately 39 days |
| Number of participants who discontinue study intervention due to an AE |
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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:
History or presence of any of the following:
Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
History of cancer (malignancy)
Unable to refrain from or anticipants the use of: Unable to refrain from or anticipates the use of: Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion ( Site 0001) | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| C034635 | fludrocortisone acetate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Prednisone | Drug | Administered at a dose of 2.5 mg or 5 mg dependent on HRT dosing regimen via oral tablets. |
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| Fludrocortisone acetate | Drug | Administered at a dose of 0.05 mg per HRT dosing regimen via oral tablets. |
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| Diltiazem hydrocholoride | Drug | Administered at a dose of 240 mg per dosing regimen via oral capsule (extended-release). |
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CL/F of MK-5684 in plasma will be determined.
| Predose, and at designated timepoints up to 120 hours post-dose |
| Apparent volume of distribution during terminal phase (Vz/F) of MK-5684 in plasma | Vz/F of MK-5684 in plasma will be determined. | Predose, and at designated timepoints up to 120 hours post-dose |
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. |
| Up to approximately 39 days |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |