Prostatic NeoplasmsPhase 1NCT06554639
A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)
A Phase 1 study testing MK-5684, Prednisone and Fludrocortisone acetate in people with Prostatic Neoplasms, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- MK-5684, Prednisone and Fludrocortisone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2024to 29 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Prostatic Neoplasms
- Being tested
- MK-5684, Prednisone, Fludrocortisone acetate, Diltiazem hydrocholoride
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-5684Drug
Administered via oral tablet per dosing regimen.
PrednisoneDrug
Administered at a dose of 2.5 mg or 5 mg dependent on HRT dosing regimen via oral tablets.
Fludrocortisone acetateDrug
Administered at a dose of 0.05 mg per HRT dosing regimen via oral tablets.
Diltiazem hydrocholorideDrug
Administered at a dose of 240 mg per dosing regimen via oral capsule (extended-release).
| Study group | Role | What they receive |
|---|---|---|
| MK-5684 Period 1 | Experimental | 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. Receives: Drug: MK-5684; Drug: Prednisone; Drug: Fludrocortisone acetate |
| MK-5684 Period 2 | Experimental | 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. Receives: Drug: MK-5684; Drug: Prednisone; Drug: Fludrocortisone acetate; Drug: Diltiazem hydrocholoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma
AUC0-inf of MK-5684 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 120 hours post-dose
Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-5684 in plasma
AUC0-last of MK-5684 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 120 hours post-dose
Area under the concentration versus time curve from 0 to Hour 24 (AUC0-24) of MK-5684 in plasma
AUC0-24 of MK-5684 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 24 hours post-dose
Maximum concentration (Cmax) of MK-5684 in plasma
Cmax of MK-5684 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 120 hours post-dose
Time to Maximum concentration (Tmax) of MK-5684 in plasma
Tmax of MK-5684 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 120 hours post-dose
Apparent terminal half-life (t1/2) of MK-5684 in plasma
t1/2 of MK-5684 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 120 hours post-dose
Apparent Clearance (CL/F) of MK-5684 in plasma
CL/F of MK-5684 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 120 hours post-dose
Apparent volume of distribution during terminal phase (Vz/F) of MK-5684 in plasma
Vz/F of MK-5684 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 120 hours post-dose
Secondary outcomes (2)
Number of participants who experience one or more adverse events (AEs)
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.
Measured: Up to approximately 39 days
Number of participants who discontinue study intervention due to an AE
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.
Measured: Up to approximately 39 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start11 Jul 2024
- Primary completion5 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554639
- Sponsor's protocol ID
- 5684-011
- Other IDs
- MK-5684-011
- Status last verified
- Oct 2024
- First submitted
- 12 Aug 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06554639
- Acronym / sponsor ID
- 5684-011
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-5684 Period 1 | Experimental | Drug: MK-5684, Drug: Prednisone, Drug: Fludrocortisone acetateOn 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 | Experimental | Drug: MK-5684, Drug: Prednisone, Drug: Fludrocortisone acetate, Drug: Diltiazem hydrocholorideThere 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- History or presence of any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-5684Administered via oral tablet per dosing regimen. | Drug | MK-5684 Period 1, MK-5684 Period 2 |
| PrednisoneAdministered at a dose of 2.5 mg or 5 mg dependent on HRT dosing regimen via oral tablets. | Drug | MK-5684 Period 1, MK-5684 Period 2 |
| Fludrocortisone acetateAdministered at a dose of 0.05 mg per HRT dosing regimen via oral tablets. | Drug | MK-5684 Period 1, MK-5684 Period 2 |
| Diltiazem hydrocholorideAdministered at a dose of 240 mg per dosing regimen via oral capsule (extended-release). | Drug | MK-5684 Period 2 |
Primary outcome
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
Vz/F of MK-5684 in plasma will be determined.
2 secondary outcomes
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to approximately 39 days
Number of participants who discontinue study intervention due to an AE
Time frame: Up to approximately 39 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-5684, Prednisone and Fludrocortisone acetate in people with Prostatic Neoplasms, run by Merck Sharp & Dohme LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma (time frame: Predose, and at designated timepoints up to 120 hours post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.