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Completed

NCT Number: NCT07025551

A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Clinical Trials ( Site 0001)

Chandler, Arizona, 85225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

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 surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb)
  • Is positive for Hepatitis C Virus (HCV)

Treatment and study plan

MK-8527

Drug

Oral administration

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Number of Participants Who Experience One or More Adverse Events (AEs)

    Time frame: Up to approximately 29 days

    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.

  2. Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to approximately 29 days

    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.

  3. 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

    Blood samples will be collected to determine the AUC0-inf of MK-8527-TP.

  4. 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

    Blood samples will be collected to determine the AUC0-672 of MK-8527-TP.

  5. Cmax of MK-8527-TP in PBMCs

    Time frame: Predose and at designated timepoints up to 672 hours post dose

    Blood samples will be collected to determine the Cmax of MK-8527-TP.

  6. Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs

    Time frame: Predose and at designated timepoints up to 672 hours post dose

    Blood samples will be collected to determine the C672 of MK-8527-TP.

  7. Tmax of MK-8527-TP in PBMCs

    Time frame: Predose and at designated timepoints up to 672 hours post dose

    Blood samples will be collected to determine the Tmax of MK-8527-TP.

  8. T1/2 of MK-8527-TP in PBMCs

    Time frame: Predose and at designated timepoints up to 672 hours post dose

    Blood samples will be collected to determine the Tmax of MK-8527-TP.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Mild and Moderate Hepatic Impairment

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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