A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
- Registration Number
- NCT06295796
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate Renal Impairment MK-8527 Participants with moderate renal impairment receive a single dose of MK-8527 on Day 1. Severe Renal Impairment MK-8527 Participants with severe renal impairment receive a single dose of MK-8527 on Day 1. Healthy MK-8527 Healthy participants receive a single dose of MK-8527 on Day 1.
- Primary Outcome Measures
Name Time Method Time to Maximum concentration (Tmax) of MK-8527 in plasma 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.
Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma 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.
Apparent terminal half-life (t1/2) of MK-8527 in plasma 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.
Apparent Clearance (CL/F) of MK-8527 in plasma 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.
Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma 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.
Area under the concentration versus time curve from time 0 to infinity (AUC0-inf) of MK-8527 in plasma 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.
Maximum concentration (Cmax) of MK-8527 in plasma 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.
- Secondary Outcome Measures
Name Time Method AUC0-inf of MK-8527-TP in PBMCs 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.
Cmax 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 will be determined.
Concentration at 168 hours (C168) of MK-8527-TP in PBMCs 168 hours post dose C168 of MK-8527-TP in PBMCs will be determined.
Concentration at 672 hours (C672) of MK-8527-TP in PBMCs 672 hours post dose C672 of MK-8527-TP in PBMCs will be determined.
Number of participants who discontinue study due to an AE 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.
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-last of MK-8527-TP in PBMCs will be determined.
Number of participants who experience one or more adverse events (AEs) 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.
Tmax of MK-8527-TP in PBMCs 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.
t1/2 of MK-8527-TP in PBMCs 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.
Trial Locations
- Locations (1)
Research by Design ( Site 0001)
🇺🇸Chicago, Illinois, United States