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Completed

NCT Number: NCT06295796

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

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research by Design ( Site 0001)

Chicago, Illinois, 60643, 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:

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.

Treatment and study plan

MK-8527

Drug

Oral Capsule

Primary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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

  5. 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

    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).

  6. 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

    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).

  7. 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

    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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

    Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. 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.

  4. 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

    Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. 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.

  5. Cmax of MK-8527-TP in PBMCs

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

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

  6. Concentration at 168 Hours (C168) of MK-8527-TP in PBMCs

    Time frame: 168 hours post dose

    Blood samples were collected at pre-specified time points to determine the C168 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Geometric mean of C168 of MK-8527-TP in PBMCs was determined.

  7. Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs in Participants With Moderate and Severe Renal Impairment

    Time frame: 672 hours post dose

    Blood samples were collected at pre-specified time points to determine the C672 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Geometric mean of C672 of MK-8527-TP in PBMCs was determined.

  8. C672 of MK-8527-TP in PBMCs in Healthy Participants

    Time frame: 672 hours post dose

    Blood samples were collected at pre-specified time points to determine the C672 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Since ≤ 50% of healthy participants had BLQ values, the BLQ value was set to zero and the median, minimum, and maximum was reported for C672.

  9. Tmax of MK-8527-TP in PBMCs

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

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

  10. 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

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

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 Moderate and Severe Renal Impairment

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2024
Registry last updated
Feb 17, 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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