A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Renal Impairment

Treatments: Drug: MK-8527

Study type: Interventional

Funder types: Industry

Identifiers

NCT06295796

MK-8527-008 (Other Identifier)

8527-008

Details and patient eligibility

About

The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.

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:

Moderate and Severe RI

• With the exception of RI, is in sufficient health for study participation.
• Has stable renal function.

Healthy

• Matches mean age to participants with moderate and severe RI.
• Has normal renal function.

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

All participants

• History of cancer (malignancy).
• Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV).
• Had a major surgery or lost significant volume of blood within 56 days prior to dosing.
• Donated plasma within 7 days prior to dosing.

Moderate and Severe RI

• Failed renal transplant or had a nephrectomy.
• End stage renal disease requiring dialysis.
• Any significant arrhythmia or conduction abnormality.
• Has non-sustained or sustained ventricular tachycardia.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

18 participants in 3 patient groups

Moderate Renal Impairment

Experimental group

Description:

Participants with moderate renal impairment receive a single dose of MK-8527 on Day 1.

Treatment:

Drug: MK-8527

Severe Renal Impairment

Experimental group

Description:

Participants with severe renal impairment receive a single dose of MK-8527 on Day 1.

Treatment:

Drug: MK-8527

Healthy

Experimental group

Description:

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

Treatment:

Drug: MK-8527