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

April 25, 2024 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate Renal Impairment
Participants with moderate renal impairment receive a single dose of MK-8527 on Day 1.
Drug: MK-8527
Oral Capsule
Experimental: Severe Renal Impairment
Participants with severe renal impairment receive a single dose of MK-8527 on Day 1.
Drug: MK-8527
Oral Capsule
Experimental: Healthy
Healthy participants receive a single dose of MK-8527 on Day 1.
Drug: MK-8527
Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma
Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
AUC0-last of MK-8527 in plasma will be determined.
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
Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
AUC0-inf of MK-8527 in plasma will be determined.
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
Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Cmax of MK-8527 in plasma will be determined.
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
Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Tmax of MK-8527 in plasma will be determined.
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
Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
t1/2 of MK-8527 in plasma will be determined.
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
Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
CL/F of MK-8527 in plasma will be determined.
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
Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Vz/F of MK-8527 in plasma will be determined.
Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to approximately 29 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 29 days
Number of participants who discontinue study due to an AE
Time Frame: Up to approximately 29 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 29 days
AUC0-last of MK-8527-triphosphate (TP) in peripheral blood mononuclear cells (PBMCs)
Time Frame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
AUC0-last of MK-8527-TP in PBMCs will be determined.
Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
AUC0-inf of MK-8527-TP in PBMCs
Time Frame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
AUC0-inf of MK-8527-TP in PBMCs will be determined.
Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
Cmax of MK-8527-TP in PBMCs
Time Frame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
Cmax of MK-8527-TP in PBMCs will be determined.
Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
Concentration at 168 hours (C168) of MK-8527-TP in PBMCs
Time Frame: 168 hours post dose
C168 of MK-8527-TP in PBMCs will be determined.
168 hours post dose
Concentration at 672 hours (C672) of MK-8527-TP in PBMCs
Time Frame: 672 hours post dose
C672 of MK-8527-TP in PBMCs will be determined.
672 hours post dose
Tmax of MK-8527-TP in PBMCs
Time Frame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
Tmax of MK-8527-TP in PBMCs will be determined.
Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
t1/2 of MK-8527-TP in PBMCs
Time Frame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
t1/2 of MK-8527-TP in PBMCs will be determined.
Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 17, 2024

Primary Completion (Estimated)

April 14, 2025

Study Completion (Estimated)

April 14, 2025

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8527-008
  • MK-8527-008 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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