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

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 1

Conditions: Hepatic Impairment; Healthy Participants

Treatments: Drug: MK-8527

Study type: Interventional

Funder types: Industry

Identifiers

NCT07025551

8527-015

MK-8527-015 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Mild Hepatic Impairment (Group 1)

Experimental group

Description:

All participants will receive a single dose of MK-8527 on Day 1.

Treatment:

Drug: MK-8527

Moderate Hepatic Impairment (Group 2)

Experimental group

Description:

All participants will receive a single dose of MK-8527 on Day 1.

Treatment:

Drug: MK-8527

Healthy (Group 3)

Experimental group

Description:

All participants will receive a single dose of MK-8527 on Day 1.

Treatment:

Drug: MK-8527