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

NCT06295796 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 8527-008MK-8527-008
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (7)

• Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma

  Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527 in participant's plasma. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. AUC0-last was calculated using noncompartmental analysis.

  Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose

• Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma

  Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527 in participant's plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.

  Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose

• Maximum Concentration (Cmax) of MK-8527 in Plasma

  Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527 in participant's plasma. Cmax was defined as the maximum observed concentration of MK-8527 in plasma after the administration of a given dose.

  Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose

• Time to Maximum Concentration (Tmax) of MK-8527 in Plasma

  Blood samples were collected at pre-specified time points to determine the tmax of MK-8527 in participant's plasma. Tmax of MK-8527 in plasma was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration

  Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose

• Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma

  Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527 in participant's plasma. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz).

  Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose

• Apparent Clearance (CL/F) of MK-8527 in Plasma

  Blood samples were collected at pre-specified time points to determine the CL/F of MK-8527 in participant's plasma. CL/F was defined as dose/(AUC0-inf).

  Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose

• Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 in Plasma

  Blood samples were collected at pre-specified time points to determine the Vz/F of MK-8527 in participant's plasma. Vz/F of MK-8527 in plasma was determined using the formula Dose/(AUC0-inf × λz).

  Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose

Secondary Outcomes (10)

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

  Up to approximately 29 days

• Number of Participants Who Discontinue Study Due to an AE

  Up to approximately 29 days

• AUC0-last of MK-8527-triphosphate (TP) in Peripheral Blood Mononuclear Cells (PBMCs)

  Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose

• AUC0-inf of MK-8527-TP in PBMCs

  Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose

• Cmax of MK-8527-TP in PBMCs

  Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose

Study Arms (3)

Moderate Renal Impairment

EXPERIMENTAL

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

Drug: MK-8527

Severe Renal Impairment

EXPERIMENTAL

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

Drug: MK-8527

Healthy

EXPERIMENTAL

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

Drug: MK-8527

Interventions

MK-8527 DRUG

Oral Capsule

Healthy; Moderate Renal Impairment; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Research by Design ( Site 0001)

Chicago, Illinois, 60643, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: June 20, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)