Hepatic ImpairmentPhase 1NCT06860243
A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)
A Phase 1 study testing Opevesostat, Prednisone and Fludrocortisone acetate in people with Hepatic Impairment and Healthy Participants, run by Merck Sharp & Dohme LLC at 2 sites in United States.
Trial summary
Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer. The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic [PK] study). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Participants
- What is being tested?
- Opevesostat, 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
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2025to 19 Feb 2026
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
The main inclusion criteria include but are not limited to the following:
- All participants:
- Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing
- Has body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2
- Participants with moderate hepatic impairment:
- Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
The main exclusion criteria include but are not limited to the following:
- All participants:
- 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)
- Has a history of cancer (malignancy)
- Has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Participants with moderate hepatic impairment
- Has unstable electrolyte abnormalities or electrolyte abnormalities that are considered difficult to manage for participants with hepatic impairment
- Has a history of liver or other solid organ transplantation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Pharmacology of Miami ( Site 0002)
Miami, Florida, 33172
Texas Liver Institute ( Site 0001)
San Antonio, Texas, 78215
About this study
Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Moderate Hepatic Impairment
Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer.
The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic [PK] study). Researchers will compare what happens to opevesostat in the body when it is given to healthy participants and participants with moderate hepatic (liver) impairment.
- Conditions
- Hepatic Impairment, Healthy Participants
- Being tested
- Opevesostat, Prednisone, Fludrocortisone acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpevesostatDrug
Also called MK-5684
Oral film-coated tablet
PrednisoneDrug
Oral tablet
Fludrocortisone acetateDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | On Day 1, participants with moderate hepatic impairment will receive a single oral dose of opevesostat under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. Participants with moderate hepatic impairment will receive another dose of HRT on Day 2. Receives: Drug: Opevesostat; Drug: Prednisone; Drug: Fludrocortisone acetate |
| Healthy | Experimental | On Day 1, healthy participants will receive a single oral dose of opevesostat under fasting conditions and a single dose of HRT (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. Receives: Drug: Opevesostat; Drug: Prednisone; Drug: Fludrocortisone acetate |
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 (AUC0-inf) of Opevesestat
Plasma samples will be collected to determine the AUC0-inf of opevesostat.
Measured: At designated timepoints (up to approximately 96 hours post-dose)
Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Opevesestat
Plasma samples will be collected to determine the AUC0-last of opevesostat.
Measured: At designated timepoints (up to approximately 96 hours post-dose)
Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Opevesestat
Plasma samples will be collected to determine the AUC0-24 of opevesostat.
Measured: At designated timepoints (up to approximately 24 hours post-dose)
Maximum Observed Concentration (Cmax) of Opevesestat
Plasma samples will be collected to determine the Cmax of opevesostat.
Measured: At designated timepoints (up to approximately 96 hours post-dose)
Time to Maximum Concentration (Tmax) of Opevesestat
Plasma samples will be collected to determine the Tmax of opevesostat.
Measured: At designated timepoints (up to approximately 96 hours post-dose)
Apparent Terminal Half-life (t1/2) of Opevesestat
Plasma samples will be collected to determine the t1/2 of opevesostat.
Measured: At designated timepoints (up to approximately 96 hours post-dose)
Apparent Clearance (CL/F) of Opevesestat
Plasma samples will be collected to determine the CL/F of opevesostat.
Measured: At designated timepoints (up to approximately 96 hours post-dose)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Opevesestat
Plasma samples will be collected to determine the Vz/F of opevesostat.
Measured: At designated timepoints (up to approximately 96 hours post-dose)
Secondary outcomes (2)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: Up to approximately 2 weeks
Number of Participants Who Discontinue Study Due to an AE
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: Up to approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start13 May 2025
- Primary completion9 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT06860243
- Sponsor's protocol ID
- 5684-009
- Other IDs
- MK-5684-009
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Moderate Hepatic Impairment
- ClinicalTrials.gov ID
- NCT06860243
- Acronym / sponsor ID
- 5684-009
- Conditions
- Hepatic Impairment, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 13 May 2025 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 5 Mar 2025 (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 opevesostat as a new way to treat prostate cancer.
The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic [PK] study). Researchers will compare what happens to opevesostat in the body when it is given to healthy participants and participants with moderate hepatic (liver) impairment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Drug: Opevesostat, Drug: Prednisone, Drug: Fludrocortisone acetateOn Day 1, participants with moderate hepatic impairment will receive a single oral dose of opevesostat under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. Participants with moderate hepatic impairment will receive another dose of HRT on Day 2. |
| Healthy | Experimental | Drug: Opevesostat, Drug: Prednisone, Drug: Fludrocortisone acetateOn Day 1, healthy participants will receive a single oral dose of opevesostat under fasting conditions and a single dose of HRT (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| OpevesostatAlso: MK-5684Oral film-coated tablet | Drug | Healthy, Moderate Hepatic Impairment |
| PrednisoneOral tablet | Drug | Healthy, Moderate Hepatic Impairment |
| Fludrocortisone acetateOral tablet | Drug | Healthy, Moderate Hepatic Impairment |
Primary outcome
Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Opevesestat
Time frame: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the AUC0-inf of opevesostat.
Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Opevesestat
Time frame: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the AUC0-last of opevesostat.
Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Opevesestat
Time frame: At designated timepoints (up to approximately 24 hours post-dose)
Plasma samples will be collected to determine the AUC0-24 of opevesostat.
Maximum Observed Concentration (Cmax) of Opevesestat
Time frame: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the Cmax of opevesostat.
Time to Maximum Concentration (Tmax) of Opevesestat
Time frame: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the Tmax of opevesostat.
Apparent Terminal Half-life (t1/2) of Opevesestat
Time frame: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the t1/2 of opevesostat.
Apparent Clearance (CL/F) of Opevesestat
Time frame: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the CL/F of opevesostat.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Opevesestat
Time frame: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the Vz/F of opevesostat.
2 secondary outcomes
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 2 weeks
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 2 weeks
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 24 Feb 2026.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Opevesostat, Prednisone and Fludrocortisone acetate in people with Hepatic Impairment and Healthy Participants, run by Merck Sharp & Dohme LLC at 2 sites 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?
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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (AUC0-inf) of Opevesestat (time frame: At designated timepoints (up to approximately 96 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 24 Feb 2026.