Clinical trial NCT06295796: A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Moderate and Severe Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-03-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
measure: Area under the concentration versus time curve from time 0 to infinity (AUC0-inf) of MK-8527 in plasma
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
measure: Maximum concentration (Cmax) of MK-8527 in plasma
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
measure: Time to Maximum concentration (Tmax) of MK-8527 in plasma
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
measure: Apparent terminal half-life (t1/2) of MK-8527 in plasma
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
measure: Apparent Clearance (CL/F) of MK-8527 in plasma
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
measure: Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma
timeFrame: 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:
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to approximately 29 days
measure: Number of participants who discontinue study due to an AE
timeFrame: Up to approximately 29 days
measure: AUC0-last of MK-8527-triphosphate (TP) in peripheral blood mononuclear cells (PBMCs)
timeFrame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
measure: AUC0-inf of MK-8527-TP in PBMCs
timeFrame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
measure: Cmax of MK-8527-TP in PBMCs
timeFrame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
measure: Concentration at 168 hours (C168) of MK-8527-TP in PBMCs
timeFrame: 168 hours post dose
measure: Concentration at 672 hours (C672) of MK-8527-TP in PBMCs
timeFrame: 672 hours post dose
measure: Tmax of MK-8527-TP in PBMCs
timeFrame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
measure: t1/2 of MK-8527-TP in PBMCs
timeFrame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Research by Design ( Site 0001)
state: Illinois
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: