NCT06554639CompletedPhase 1
A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)
A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Diltiazem on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 12 Aug 2024
- Start date
- 11 Jul 2024
- Primary completion date
- 5 Aug 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Prostate cancer
- NCT number
- NCT06554639
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 11 Jul 2024 to the primary completion date, 5 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Other
- The main exclusion criteria include but are not limited to the following:
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Celerion ( Site 0001) Coordinator of this site? Confirm its status | Tempe | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.