Phase 1
N=18
A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
Renal Impairment
Bottom Line
View on ClinicalTrials.gov: NCT06295796 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma — 769; 1160; 1430 nM·hr
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MK-8527 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma |
769; 1160; 1430 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma |
918; 1640; 2060 | — |
| PRIMARY Maximum Concentration (Cmax) of MK-8527 in Plasma |
112; 161; 91.7 | — |
| PRIMARY Time to Maximum Concentration (Tmax) of MK-8527 in Plasma |
0.75; 0.75; 0.99 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma |
84.2; 118; 113 | — |
| PRIMARY Apparent Clearance (CL/F) of MK-8527 in Plasma |
21.2; 11.8; 9.45 | — |
| PRIMARY Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 in Plasma |
2570; 2020; 1540 | — |
| SECONDARY Number of Participants Who Experience One or More Adverse Events (AEs) |
0; 0; 0 | — |
| SECONDARY Number of Participants Who Discontinue Study Due to an AE |
0; 0; 0 | — |
| SECONDARY AUC0-last of MK-8527-triphosphate (TP) in Peripheral Blood Mononuclear Cells (PBMCs) |
217; 493; 588 | — |
| SECONDARY AUC0-inf of MK-8527-TP in PBMCs |
235; 468; 552 | — |
| SECONDARY Cmax of MK-8527-TP in PBMCs |
1.77; 3.82; 3.18 | — |
| SECONDARY Concentration at 168 Hours (C168) of MK-8527-TP in PBMCs |
0.470; 0.948; 1.03 | — |
| SECONDARY Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs in Participants With Moderate and Severe Renal Impairment |
0.183; 0.248 | — |
| SECONDARY C672 of MK-8527-TP in PBMCs in Healthy Participants |
0.0673 | — |
| SECONDARY Tmax of MK-8527-TP in PBMCs |
23.08; 23.92; 23.01 | — |
| SECONDARY T1/2 of MK-8527-TP in PBMCs |
170; 212; 251 | — |
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.
Data sourced from ClinicalTrials.gov (NCT06295796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.