Renal Impairment Clinical Trial
Official title:
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Moderate and Severe Renal Impairment
| Verified date | April 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 18 |
| Est. completion date | April 21, 2025 |
| Est. primary completion date | April 21, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma | 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 | |
| Primary | Area under the concentration versus time curve from time 0 to infinity (AUC0-inf) of MK-8527 in plasma | 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 | |
| Primary | Maximum concentration (Cmax) of MK-8527 in plasma | 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 | |
| Primary | Time to Maximum concentration (Tmax) of MK-8527 in plasma | 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 | |
| Primary | Apparent terminal half-life (t1/2) of MK-8527 in plasma | 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 | |
| Primary | Apparent Clearance (CL/F) of MK-8527 in plasma | 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 | |
| Primary | Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma | 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 | Number of participants who experience one or more adverse events (AEs) | 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 | |
| Secondary | Number of participants who discontinue study due to an AE | 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 | |
| Secondary | AUC0-last of MK-8527-triphosphate (TP) in peripheral blood mononuclear cells (PBMCs) | 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 | |
| Secondary | AUC0-inf of MK-8527-TP in PBMCs | 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 | |
| Secondary | Cmax of MK-8527-TP in PBMCs | 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 | |
| Secondary | Concentration at 168 hours (C168) of MK-8527-TP in PBMCs | C168 of MK-8527-TP in PBMCs will be determined. | 168 hours post dose | |
| Secondary | Concentration at 672 hours (C672) of MK-8527-TP in PBMCs | C672 of MK-8527-TP in PBMCs will be determined. | 672 hours post dose | |
| Secondary | Tmax of MK-8527-TP in PBMCs | 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 | |
| Secondary | t1/2 of MK-8527-TP in PBMCs | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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