Clinical trial · Interventional
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
NCT06554639CI-TRIAL-00081606completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diltiazem hydrocholoride | Drug | — | UNRESOLVED |
| Fludrocortisone acetate | Drug | — | UNRESOLVED |
| MK-5684 | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MK-5684 Period 1
- description
- 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.
- interventionNames
- Drug: MK-5684
- Drug: Prednisone
- Drug: Fludrocortisone acetate
- type
- EXPERIMENTAL
- label
- MK-5684 Period 2
- description
- 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.
- interventionNames
- Drug: MK-5684
- Drug: Prednisone
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 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 Criteria: 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
References
Publications (0)
Data not yet available
No reference posted for this study.