A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)

Официальное название

An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-2828 in Participants With Renal Impairment

Обзор

The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial). Researchers want to learn if the PK of people with certain types of kidney disease is similar to the PK of healthy people.

Вмешательства

• Препарат MK-2828
  Oral administration

Первичные конечные точки

• Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of MK-2828 in Plasma [Срок оценки: Pre dose and at designated time points up to 192 hours post dose]
• Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of MK-2828 in Plasma [Срок оценки: Pre dose and at designated time points up to 192 hours post dose]
• Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of MK-2828 in Plasma [Срок оценки: Pre dose and at designated time points up to 24 hours post dose]
• Maximum Plasma Concentration (Cmax) of MK-2828 in Plasma [Срок оценки: Pre dose and at designated time points up to 192 hours post dose]
• Time of the Maximum Observed Concentration (Tmax) of MK-2828 in Plasma [Срок оценки: Pre dose and at designated time points up to 192 hours post dose]
• Concentration at 24 Hours Postdose (C24) of MK-2828 in Plasma [Срок оценки: At designated time points up to 24 hours post dose]
• Apparent Terminal Elimination Half-life (t1/2) of MK-2828 in Plasma [Срок оценки: Pre dose and at designated time points up to 192 hours post dose]
• Apparent Total Plasma Clearance (CL/F) of MK-2828 [Срок оценки: Pre dose and at designated time points up to 192 hours post dose]
• Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of MK-2828 in Plasma [Срок оценки: Pre dose and at designated time points up to 192 hours post dose]

Вторичные конечные точки (7)

• Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 14 days]
• Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 2 days]
• Area Under the Concentration-time Curve From Start to End of Dialysis (AUCD) of MK-2828 [Срок оценки: Prior to hemodialysis (HD) and at designated time points until day 6]
• Area Under the Concentration-time Curve Determined from the Pre-dialyzer Line (AUCCa) of MK-2828 [Срок оценки: Prior to hemodialysis (HD) and at designated time points until day 6]
• Area Under the Concentration-time Curve Determined from the Post-dialyzer Line (AUCCv) of MK-2828 [Срок оценки: Prior to hemodialysis (HD) and at designated time points until day 6]
• Dialysis Clearance (CLD) of MK-2828 Based on Plasma [Срок оценки: Prior to hemodialysis (HD) and at designated time points until day 6]
• Hemodialysis Extraction Ratio (ER_D) of MK-2828 [Срок оценки: Prior to hemodialysis (HD) and at designated time points until day 6]

Критерии участия

The main inclusion criteria include but are not limited to the following:

• Is in generally good health, with the exception of renal impairment participants. Participants with stable, chronic medical or psychiatric conditions may be included at the discretion of the investigator and the Sponsor.

Severe Renal Impairment Participants:

• Has an estimated glomerular filtration rate (eGFR) < 30 mL/min), but is not on hemodialysis (HD)

ESRD on HD Participants:

• Has ESRD maintained on stable outpatient regimen of intermittent high-flux HD at a healthcare center for > 3 months prior to study entry

The main exclusion criteria include but are not limited to the following:

Renal Impairment Participants:

• History of any illness, other than renal impairment, that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.

Healthy Matched Control Participants:

• History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Panax Clinical Research ( Site 0003) — Miami Lakes
• Floridian Clinical Research ( Site 0001) — Miami Lakes
• Orlando Clinical Research Center ( Site 0002) — Orlando

Идентификаторы

NCT: NCT07348237 · 2828-006 · MK-2828-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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