Status:
COMPLETED
A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 pharmaco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06554639
Start Date
July 11 2024
End Date
August 29 2024
Last Update
October 15 2024
Active Locations (1)
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1
Celerion ( Site 0001)
Tempe, Arizona, United States, 85283