Hepatic ImpairmentPhase 1NCT07025551
A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)
A Phase 1 study testing MK-8527 in people with Hepatic Impairment and Healthy Participants, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic [PK] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Participants
- What is being tested?
- MK-8527
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2025to 13 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 ≤ 40.0 kg/m^2
- Participants with Mild HI (Group 1) and Moderate HI (Group 2):
- Has mild or moderate hepatic impairment
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- Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
- Is generally in good health with the exception of HI
- Healthy Control Participants (Group 3):
- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- All participants:
- Has a history of cancer (malignancy)
- Has positive results for human immunodeficiency virus (HIV)
- Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
- Participants with Mild HI (Group 1) and Moderate HI (Group 2):
Show all 9Show fewer
- With the exception of HI, has a history or presence of clinically significant medical or psychiatric condition or disease
- Is positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb)
- Is positive for Hepatitis C Virus (HCV)
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Clinical Trials ( Site 0001)
Chandler, Arizona, 85225
About this study
Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Mild and Moderate Hepatic Impairment
The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic [PK] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.
- Conditions
- Hepatic Impairment, Healthy Participants
- Being tested
- MK-8527
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8527Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Mild Hepatic Impairment (Group 1) | Experimental | All participants will receive a single dose of MK-8527 on Day 1. Receives: Drug: MK-8527 |
| Moderate Hepatic Impairment (Group 2) | Experimental | All participants will receive a single dose of MK-8527 on Day 1. Receives: Drug: MK-8527 |
| Healthy (Group 3) | Experimental | All participants will receive a single dose of MK-8527 on Day 1. Receives: Drug: MK-8527 |
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 the time of the last quantifiable sample (AUC0-last) of MK-8527
Plasma samples will be collected at pre-specified timepoints to determine the AUC0-last of MK-8527.
Measured: Predose and at designated timepoints up to 168 hours post dose
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-8527
Plasma samples will be collected at pre-specified timepoints to determine the AUC0-inf of MK-8527.
Measured: Predose and at designated timepoints up to 168 hours post dose
Maximum Observed Concentration (Cmax) of MK-8527
Plasma samples will be collected at pre-specified timepoints to determine the Cmax of MK-8527.
Measured: Predose and at designated timepoints up to 168 hours post dose
Time to Maximum Concentration (Tmax) of MK-8527
Plasma samples will be collected at pre-specified timepoints to determine the Tmax of MK-8527.
Measured: Predose and at designated timepoints up to 168 hours post dose
Apparent Terminal Half-life (t1/2) of MK-8527
Plasma samples will be collected at pre-specified timepoints to determine the t1/2 of MK-8527.
Measured: Predose and at designated timepoints up to 168 hours post dose
Apparent Clearance (CL/F) of MK-8527
Plasma samples will be collected at pre-specified timepoints to determine the CL/F of MK-8527.
Measured: Predose and at designated timepoints up to 168 hours post dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527
Plasma samples will be collected at pre-specified timepoints to determine the Vz/F of MK-8527.
Measured: Predose and at designated timepoints up to 168 hours post dose
Secondary outcomes (8)
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 29 days
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 29 days
AUC0-inf of MK-8527-triphosphate (TP) in peripheral blood mononuclear cell (PBMCs)
Blood samples will be collected to determine the AUC0-inf of MK-8527-TP.
Measured: Predose and at designated timepoints up to 672 hours post dose
Area under the concentration versus time curve from 0 to 672 hours after dosing (AUC0-672hrs) of MK-8527-TP in PBMCs
Blood samples will be collected to determine the AUC0-672 of MK-8527-TP.
Measured: At designated timepoints pre dose and up to approximately 672 hours post dose
Cmax of MK-8527-TP in PBMCs
Blood samples will be collected to determine the Cmax of MK-8527-TP.
Measured: Predose and at designated timepoints up to 672 hours post dose
Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs
Blood samples will be collected to determine the C672 of MK-8527-TP.
Measured: Predose and at designated timepoints up to 672 hours post dose
Tmax of MK-8527-TP in PBMCs
Blood samples will be collected to determine the Tmax of MK-8527-TP.
Measured: Predose and at designated timepoints up to 672 hours post dose
T1/2 of MK-8527-TP in PBMCs
Blood samples will be collected to determine the Tmax of MK-8527-TP.
Measured: Predose and at designated timepoints up to 672 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start19 Sep 2025
- Primary completion13 Feb 2026
- Study completion13 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
- 18 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
- NCT07025551
- Sponsor's protocol ID
- 8527-015
- Other IDs
- MK-8527-015
- Status last verified
- Feb 2026
- First submitted
- 9 Jun 2025
- Last updated
- 27 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 27 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-8527 in Participants With Mild and Moderate Hepatic Impairment
- ClinicalTrials.gov ID
- NCT07025551
- Acronym / sponsor ID
- 8527-015
- Conditions
- Hepatic Impairment, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 17 Jun 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.
The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic [PK] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Hepatic Impairment (Group 1) | Experimental | Drug: MK-8527All participants will receive a single dose of MK-8527 on Day 1. |
| Moderate Hepatic Impairment (Group 2) | Experimental | Drug: MK-8527All participants will receive a single dose of MK-8527 on Day 1. |
| Healthy (Group 3) | Experimental | Drug: MK-8527All participants will receive a single dose of MK-8527 on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 ≤ 40.0 kg/m^2
- Has mild or moderate hepatic impairment
- Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
- Is generally in good health with the exception of HI
Key exclusion criteria (9 listed)
- Has a history of cancer (malignancy)
- Has positive results for human immunodeficiency virus (HIV)
- Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
- With the exception of HI, has a history or presence of clinically significant medical or psychiatric condition or disease
- Is positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb)
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-8527Oral administration | Drug | Healthy (Group 3), Mild Hepatic Impairment (Group 1), Moderate Hepatic Impairment (Group 2) |
Primary outcome
Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of MK-8527
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the AUC0-last of MK-8527.
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-8527
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the AUC0-inf of MK-8527.
Maximum Observed Concentration (Cmax) of MK-8527
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the Cmax of MK-8527.
Time to Maximum Concentration (Tmax) of MK-8527
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the Tmax of MK-8527.
Apparent Terminal Half-life (t1/2) of MK-8527
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the t1/2 of MK-8527.
Apparent Clearance (CL/F) of MK-8527
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the CL/F of MK-8527.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the Vz/F of MK-8527.
8 secondary outcomes
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 29 days
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 29 days
AUC0-inf of MK-8527-triphosphate (TP) in peripheral blood mononuclear cell (PBMCs)
Time frame: Predose and at designated timepoints up to 672 hours post dose
Area under the concentration versus time curve from 0 to 672 hours after dosing (AUC0-672hrs) of MK-8527-TP in PBMCs
Time frame: At designated timepoints pre dose and up to approximately 672 hours post dose
Cmax of MK-8527-TP in PBMCs
Time frame: Predose and at designated timepoints up to 672 hours post dose
Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs
Time frame: Predose and at designated timepoints up to 672 hours post dose
Tmax of MK-8527-TP in PBMCs
Time frame: Predose and at designated timepoints up to 672 hours post dose
T1/2 of MK-8527-TP in PBMCs
Time frame: Predose and at designated timepoints up to 672 hours post dose
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 27 Feb 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- 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
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-8527 in people with Hepatic Impairment and Healthy Participants, 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 10 inclusion and 9 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 27 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 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 the time of the last quantifiable sample (AUC0-last) of MK-8527 (time frame: Predose and at designated timepoints up to 168 hours post dose). The study lists 7 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 27 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.