A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)
- Conditions
- Prostatic Neoplasms
- Interventions
- Registration Number
- NCT06554639
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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
The main exclusion criteria include but are not limited to the following:
-
History or presence of any of the following:
- Adrenal insufficiency
- Hepatic or renal impairment
- Clinically significant hypotension, cardiac arrhythmia, cardiac conduction abnormalities, or recurrent unexplained syncopal events
- Second- or third-degree Atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker)
- Clinically significant sick sinus syndrome
- Presence of any systemic fungal infection
- Chronic infection
- Glaucoma
- Hypothyroidism
- Stomach ulcer
- Ocular herpes simplex
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description MK-5684 Period 2 Diltiazem hydrocholoride 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. MK-5684 Period 1 Prednisone 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. MK-5684 Period 1 Fludrocortisone acetate 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. MK-5684 Period 2 MK-5684 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. MK-5684 Period 1 MK-5684 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. MK-5684 Period 2 Prednisone 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. MK-5684 Period 2 Fludrocortisone acetate 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.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Celerion ( Site 0001)
🇺🇸Tempe, Arizona, United States