Metastatic Prostate CancerPhase 1NCT06566989
A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)
A Phase 1 study testing [¹⁴C]Opevesostat, Prednisone and Fludrocortisone in people with Metastatic Prostate Cancer, run by Merck Sharp & Dohme LLC at 1 site in United Kingdom.
Trial summary
This is a study of opevesostat in healthy adult male participants. The purpose of this study is to understand the absorption, distribution, metabolism, and elimination of opevesostat in humans, as well as its pharmacokinetics (PK), metabolic profile, and safety and tolerability. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- [¹⁴C]Opevesostat, Prednisone and Fludrocortisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Sep 2024to 17 Oct 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a healthy male according to the assessment of the investigator
- Has a body mass index of 18.0 to 32.0 kg/m2
- Has regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
Who cannot join
- Has the presence or history of clinically significant allergy requiring treatment
- Has a history of adrenal insufficiency
- Has veins not suitable for multiple venipunctures/cannulation
- Has previously taken part in more than 3 radiolabeled drug studies in the last 12 months
- Has donated blood or plasma within the previous 3 months or lost greater than 400 mL of blood
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences ( Site 0001)
Nottingham, Nottinghamshire, NG11 6JS
About this study
Official title: An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-5684 in Healthy Male Participants
This is a study of opevesostat in healthy adult male participants. The purpose of this study is to understand the absorption, distribution, metabolism, and elimination of opevesostat in humans, as well as its pharmacokinetics (PK), metabolic profile, and safety and tolerability.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- [¹⁴C]Opevesostat, Prednisone, Fludrocortisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁴C]OpevesostatDrug
Also called MK-5684
Oral solution
PrednisoneDrug
Also called RAYOS®, STERAPRED®, DELTASONE®
Tablet
FludrocortisoneDrug
Also called FLORINEF®
Tablet
| Study group | Role | What they receive |
|---|---|---|
| [¹⁴C]Opevesostat | Experimental | On Day 1, participants receive a single dose of [¹⁴C]opevesostat as an oral solution. Participants then receive single doses of 5.0 mg prednisone and 0.05 mg fludrocortisone tablets 4 hours later as hormone replacement therapy. Receives: Drug: [¹⁴C]Opevesostat; Drug: Prednisone; Drug: Fludrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative amount of total radioactivity excreted in urine (CumAeu) after administration of single-dose [¹⁴C]Opevesostat
Urine samples will be collected at pre-specified timepoints and used to determine CumAeu.
Measured: Predose and at designated time points (up to 8 days)
Cumulative amount of total radioactivity excreted in feces (CumAef) after administration of single-dose [¹⁴C]Opevesostat
Fecal samples will be collected at pre-specified timepoints and used to determine CumAef.
Measured: Predose and at designated time points (up to 8 days)
Cumulative percentage of total radioactivity excreted in urine (Cumfeu) after administration of single-dose [¹⁴C]Opevesostat
Urine samples will be collected at pre-specified timepoints and used to determine CumFeu.
Measured: Predose and at designated time points (up to 8 days)
Cumulative percentage of total radioactivity excreted in feces (Cumfef) after administration of single-dose [¹⁴C]Opevesostat
Fecal samples will be collected at pre-specified timepoints and used to determine Cumfef.
Measured: Predose and at designated time points (up to 8 days)
Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-t of opevesostat.
Measured: Predose and at designated time points (up to 8 days)
Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf)
Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-inf of opevesostat.
Measured: Predose and at designated time points (up to 8 days)
Plasma Opevesostat Pharmacokinetics: Maximum observed concentration (Cmax)
Plasma samples will be collected at pre-specified timepoints and used to determine Cmax of opevesostat.
Measured: Predose and at designated time points (up to 8 days)
Plasma Opevesostat Pharmacokinetics: Time of maximum observed concentration (Tmax)
Plasma samples will be collected at pre-specified timepoints and used to determine Tmax of opevesostat.
Measured: Predose and at designated time points (up to 8 days)
Plasma Opevesostat Pharmacokinetics: Terminal elimination half-life (t1/2)
Plasma samples will be collected at pre-specified timepoints and used to determine t1/2 of opevesostat.
Measured: Predose and at designated time points (up to 8 days)
Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-t of total radioactivity.
Measured: Predose and at designated time points (up to 8 days)
Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf)
Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-inf of total radioactivity.
Measured: Predose and at designated time points (up to 8 days)
Plasma Total Radioactivity Pharmacokinetics: Maximum observed concentration (Cmax)
Plasma samples will be collected at pre-specified timepoints and used to determine Cmax of total radioactivity.
Measured: Predose and at designated time points (up to 8 days)
Plasma Total Radioactivity Pharmacokinetics: Time of maximum observed concentration (Tmax)
Plasma samples will be collected at pre-specified timepoints and used to determine Tmax of total radioactivity.
Measured: Predose and at designated time points (up to 8 days)
Plasma Total Radioactivity Pharmacokinetics: Terminal elimination half-life (t1/2)
Plasma samples will be collected at pre-specified timepoints and used to determine t1/2 of total radioactivity.
Measured: Predose and at designated time points (up to 8 days)
Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity
Plasma samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Measured: Predose and at designated time points (up to 8 days)
Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity
Urine samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Measured: Predose and at designated time points (up to 8 days)
Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity
Fecal samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Measured: Predose and at designated time points (up to 8 days)
Secondary outcomes (2)
Number of Participants with 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants who experienced an AE will be reported.
Measured: Up to approximately 8 days
Number of Participants who Discontinue from the Study 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants who discontinue from the study due to an AE will be reported.
Measured: Up to approximately 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start19 Sep 2024
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566989
- Sponsor's protocol ID
- 5684-008
- Other IDs
- MK-5684-008, 1010197
- Status last verified
- Oct 2024
- First submitted
- 20 Aug 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-5684 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06566989
- Acronym / sponsor ID
- 5684-008
- Conditions
- Metastatic Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 22 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.
This is a study of opevesostat in healthy adult male participants. The purpose of this study is to understand the absorption, distribution, metabolism, and elimination of opevesostat in humans, as well as its pharmacokinetics (PK), metabolic profile, and safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [¹⁴C]Opevesostat | Experimental | Drug: [¹⁴C]Opevesostat, Drug: Prednisone, Drug: FludrocortisoneOn Day 1, participants receive a single dose of [¹⁴C]opevesostat as an oral solution. Participants then receive single doses of 5.0 mg prednisone and 0.05 mg fludrocortisone tablets 4 hours later as hormone replacement therapy. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is a healthy male according to the assessment of the investigator
- Has a body mass index of 18.0 to 32.0 kg/m2
- Has regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
Key exclusion criteria (5 listed)
- Has the presence or history of clinically significant allergy requiring treatment
- Has a history of adrenal insufficiency
- Has veins not suitable for multiple venipunctures/cannulation
- Has previously taken part in more than 3 radiolabeled drug studies in the last 12 months
- Has donated blood or plasma within the previous 3 months or lost greater than 400 mL of blood
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 |
|---|---|---|
| [¹⁴C]OpevesostatAlso: MK-5684Oral solution | Drug | [¹⁴C]Opevesostat |
| PrednisoneAlso: RAYOS®, STERAPRED®, DELTASONE®Tablet | Drug | [¹⁴C]Opevesostat |
| FludrocortisoneAlso: FLORINEF®Tablet | Drug | [¹⁴C]Opevesostat |
Primary outcome
Cumulative amount of total radioactivity excreted in urine (CumAeu) after administration of single-dose [¹⁴C]Opevesostat
Time frame: Predose and at designated time points (up to 8 days)
Urine samples will be collected at pre-specified timepoints and used to determine CumAeu.
Cumulative amount of total radioactivity excreted in feces (CumAef) after administration of single-dose [¹⁴C]Opevesostat
Time frame: Predose and at designated time points (up to 8 days)
Fecal samples will be collected at pre-specified timepoints and used to determine CumAef.
Cumulative percentage of total radioactivity excreted in urine (Cumfeu) after administration of single-dose [¹⁴C]Opevesostat
Time frame: Predose and at designated time points (up to 8 days)
Urine samples will be collected at pre-specified timepoints and used to determine CumFeu.
Cumulative percentage of total radioactivity excreted in feces (Cumfef) after administration of single-dose [¹⁴C]Opevesostat
Time frame: Predose and at designated time points (up to 8 days)
Fecal samples will be collected at pre-specified timepoints and used to determine Cumfef.
Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-t of opevesostat.
Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf)
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-inf of opevesostat.
Plasma Opevesostat Pharmacokinetics: Maximum observed concentration (Cmax)
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine Cmax of opevesostat.
Plasma Opevesostat Pharmacokinetics: Time of maximum observed concentration (Tmax)
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine Tmax of opevesostat.
Plasma Opevesostat Pharmacokinetics: Terminal elimination half-life (t1/2)
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine t1/2 of opevesostat.
Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-t of total radioactivity.
Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf)
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-inf of total radioactivity.
Plasma Total Radioactivity Pharmacokinetics: Maximum observed concentration (Cmax)
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine Cmax of total radioactivity.
Plasma Total Radioactivity Pharmacokinetics: Time of maximum observed concentration (Tmax)
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine Tmax of total radioactivity.
Plasma Total Radioactivity Pharmacokinetics: Terminal elimination half-life (t1/2)
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine t1/2 of total radioactivity.
Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity
Time frame: Predose and at designated time points (up to 8 days)
Plasma samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity
Time frame: Predose and at designated time points (up to 8 days)
Urine samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity
Time frame: Predose and at designated time points (up to 8 days)
Fecal samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
2 secondary outcomes
Number of Participants with One or More Adverse Events (AEs)
Time frame: Up to approximately 8 days
Number of Participants who Discontinue from the Study Due to an AE
Time frame: Up to approximately 8 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 23 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 [¹⁴C]Opevesostat, Prednisone and Fludrocortisone in people with Metastatic Prostate Cancer, run by Merck Sharp & Dohme LLC at 1 site in United Kingdom.
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 3 inclusion and 5 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 23 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 Kingdom. 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?
Cumulative amount of total radioactivity excreted in urine (CumAeu) after administration of single-dose [¹⁴C]Opevesostat (time frame: Predose and at designated time points (up to 8 days)). The study lists 17 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 23 Oct 2024.