A Clinical Trial of Nemtabrutinib in Participants With Severe Kidney Disease (MK-1026-027)

Официальное название

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

Обзор

The purpose of this study is to learn what happens to nemtabrutinib in a person's body when given to participants with severe kidney disease and to healthy participants.

Вмешательства

• Препарат Nemtabrutinib
  Oral administration

Первичные конечные точки

• Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib in Plasma [Срок оценки: At designated timepoints up to approximately 336 hours postdose]

Вторичные конечные точки (10)

• Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Nemtabrutinib [Срок оценки: At designated timepoints up to approximately 336 hours postdose]
• Area Under the Concentration Versus Time Curve from 0 to 24 Hours Postdose (AUC0-24) of Nemtabrutinib [Срок оценки: Up to approximately 24 hours postdose]
• Maximum Plasma Concentration (Cmax) of Nemtabrutinib in Plasma [Срок оценки: At designated timepoints up to approximately 336 hours postdose]
• Concentration at 24 Hours Postdose (C24) of Nemtabrutinib in Plasma [Срок оценки: Up to approximately 24 hours postdose]
• Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib in Plasma [Срок оценки: At designated timepoints up to approximately 336 hours postdose]
• Time of the Maximum Observed Concentration (t1/2) of Nemtabrutinib in Plasma [Срок оценки: At designated timepoints up to approximately 336 hours postdose]
• Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib [Срок оценки: At designated timepoints up to approximately 336 hours postdose]
• Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Nemtabrutinib in Plasma [Срок оценки: At designated timepoints up to approximately 336 hours postdose]
• Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 15 days]
• Number of Participants Who Discontinue From the Study Due to an AE [Срок оценки: Up to approximately 15 days]

Критерии участия

Критерии включения

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

All participants:

• Has a body mass index (BMI) ≥18.0 and ≤40.0 kg/m\^2

Participants with Severe Renal impairment (RI):

• The participant has stable renal function as determined by historical measurements.

Healthy volunteers:

• Is medically healthy with no clinically significant medical history

Критерии исключения

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

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07734610 · 1026-027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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