Clinical trial NCT07025551: A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)
Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Mild and Moderate Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy Participants
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

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
* Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology

Participants with Mild HI (Group 1) and Moderate HI (Group 2):

* Has mild or moderate hepatic impairment
* 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

Exclusion Criteria:

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):

* With the exception of HI, has a history or presence of clinically significant medical or psychiatric condition or disease
* Is positive for Hepatitis B Virus (HBV)
* Is positive for Hepatitis C Virus (HCV)

Primary outcomes:
measure: Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of MK-8527
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-8527
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Maximum Observed Concentration (Cmax) of MK-8527
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Time to Maximum Concentration (Tmax) of MK-8527
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Apparent Terminal Half-life (t1/2) of MK-8527
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Apparent Clearance (CL/F) of MK-8527
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527
timeFrame: Predose and at designated timepoints up to 168 hours post dose
Secondary outcomes:
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 29 days
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 29 days
measure: AUC0-inf of MK-8527-triphosphate (TP) in peripheral blood mononuclear cell (PBMCs)
timeFrame: Predose and at designated timepoints up to 672 hours post dose
measure: Area under the concentration versus time curve from 0 to 672 hours after dosing (AUC0-672hrs) of MK-8527-TP in PBMCs
timeFrame: At designated timepoints pre dose and up to approximately 672 hours post dose
measure: Cmax of MK-8527-TP in PBMCs
timeFrame: Predose and at designated timepoints up to 672 hours post dose
measure: Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs
timeFrame: Predose and at designated timepoints up to 672 hours post dose
measure: Tmax of MK-8527-TP in PBMCs
timeFrame: Predose and at designated timepoints up to 672 hours post dose
measure: T1/2 of MK-8527-TP in PBMCs
timeFrame: Predose and at designated timepoints up to 672 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: