A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)
Completed · Phase 1
Conditions studied: Prostatic Neoplasms
In brief
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.
Key facts
- Study ID
- NCT06554639
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 12
- Starts
- 2024-07-11
- Expected to finish
- 2024-08-29
- Last updated by the study team
- 2024-10-15
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Celerion ( Site 0001) — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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