Идёт набор NCT07682818

Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function

Фаза I С лечением Impaired Hepatic Function

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Petrelintide.
Кому может быть актуально: Состояния в реестре: Impaired Hepatic Function. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Польша, Словакия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function

Обзор

This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities. The aim of this clinical research trial is to investigate whether the pharmacokinetics (PK) of petrelintide will be different in people with hepatic impairment (HI) compared to people with normal hepatic function.

Подробное описание

This is a Phase 1, open-label, multicenter, single-dose, parallel-group, non-randomized trial to evaluate the PK, safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe HI, and participants with normal hepatic function. Allocation of participants to the hepatic function groups will be based on Child-Pugh classification.

Each participant will receive a single subcutaneous (SC) dose of petrelintide on Day 1.

Up to 18 participants with normal hepatic function and 18 participants with HI (6 participants each in the following groups: mild, moderate, or severe HI) will participate in this trial.

Вмешательства

Препарат Petrelintide
Petrelintide will be administered as a single SC injection.

Первичные конечные точки

Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide [Срок оценки: Day 1 (pre-dose) to Day 50 (Follow-up)]

Вторичные конечные точки (7)

AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide [Срок оценки: Day 1 (pre-dose) to Day 50 (Follow-up)]
Maximum Observed Plasma Concentration (Cmax) of Petrelintide [Срок оценки: Day 1 (pre-dose) to Day 50 (Follow-up)]
Time to Cmax (tmax) [Срок оценки: Day 1 (pre-dose) to Day 50 (Follow-up)]
Apparent Clearance (CL/F) of Petrelintide [Срок оценки: Day 1 (pre-dose) to Day 50 (Follow-up)]
Terminal Elimination Half-life (t1/2) of Petrelintide [Срок оценки: Day 1 (pre-dose) to Day 50 (Follow-up)]
Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide [Срок оценки: Day 1 (pre-dose) to Day 50 (Follow-up)]
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Day 1 up to Day 50]

Критерии участия

Критерии включения

All participants:

Sex: male and female participants.
Body mass index (BMI): 18.5 to 40.0 kg/m\^2, inclusive, at screening.

Additional Inclusion Criteria for Participants with Normal Hepatic Function

Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening..
Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be clinically significant by the Investigator.

Additional Inclusion Criteria for Participants with Hepatic Impairment

Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
Participants should be otherwise judged to be in acceptable health (type 2 diabetes mellitus \[T2DM\] is allowed) in the opinion of the Investigator based on a medical evaluation (including a physical examination, medical history, electrocardiogram \[ECG\], vital signs, concomitant medication and the results of laboratory safety tests) performed during the screening visit.
Participants with T2DM may be enrolled if they have/are: a. Hemoglobin A1c ≤11% at screening b. On a stable regimen for at least 8 weeks prior to screening, defined as: stable diet and exercise program, and/or, stable dose of metformin, and/or, stable dose of a sodium-glucose cotransporter-2 inhibitor.

Критерии исключения

All participants:

Known or suspected hypersensitivity to the IMP or related products.
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.

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

Здоровые добровольцы: Да