A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate

Официальное название

A Phase I Trial to Investigate the Pharmacokinetics and ECG Effects of Single Doses of Linaprazan Glurate Administered as Oral Tablets to Healthy Participants

Обзор

This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized trial designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of single oral doses of linaprazan glurate. The trial will explore the PK properties of linaprazan glurate and linaprazan as well as the cardiodynamic ECG effects, safety, and tolerability after the administration of single doses: 300 mg and 600 mg in Part I of the trial, using formulation A of linaprazan glurate, as well as 150 mg, 275 mg, and up to 2 additional dose levels, using formulation C of linaprazan glurate to reach target linaprazan mean Cmax exposure (5222 nmol/L).

Вмешательства

• Препарат Linaprazan glurate
  Linaprazan glurate base formulation, 25 mg oral tablets (300 mg and 600 mg doses). Linaprazan glurate hydrochloride (HCl), 25 mg and 50 mg (as base) oral tablets (150 mg, 275 mg and up to 2 additional dose levels).
• Препарат Placebo
  Single dose, oral tablets

Первичные конечные точки

• Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf) [Срок оценки: Up to 24 hours]
• Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast) [Срок оценки: Up to 24 hours]
• Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax) [Срок оценки: Up to 24 hours]
• Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2) [Срок оценки: Up to 24 hours]
• Measurement of Cardiodynamic ECG (QTcF) [Срок оценки: Up to 24 hours]
• Measurement of Cardiodynamic ECG (heart rate) [Срок оценки: Up to 24 hours]
• Measurement of Cardiodynamic ECG (PR interval) [Срок оценки: Up to 24 hours]
• Measurement of Cardiodynamic ECG (QRS interval) [Срок оценки: Up to 24 hours]
• Measurement of Cardiodynamic ECG (placebo-corrected QTcF) [Срок оценки: Up to 24 hours]
• Measurement of Cardiodynamic ECG (placebo-corrected heart rate) [Срок оценки: Up to 24 hours]

Критерии участия

Main inclusion Criteria:

• Willing and able to give written informed consent for participation in the study.
• Healthy male or female aged 18 to 65 years
• Body mass index ≥18.5 and ≤35.0 kg/m2.
• Prospective subjects, as well as their partners, must agree to contraception requirements

Main exclusion criteria:

• Female subjects of childbearing potential unless they agree to use highly effective methods of contraception (failure rate of <1%) from 2 weeks prior to dosing until the end-of-study visit.
• Male subjects with a partner of childbearing potential, unless they agree to use method of contraception from 2 weeks prior to dosing until the end-of-study visit.History of or current clinically significant disease as defined in the protocol
• History of or current clinically significant disease as defined in the protocol.
• History of GERD, significant acid reflux.
• Subjects who are pregnant, currently breastfeeding, or intend to become pregnant (female subjects) or father a child (male subjects) during the course of the study (i.e., from screening to end of study visit).

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Швеция · 1 центр

• CTC Clinical Trial Consultants AB — Uppsala

Идентификаторы

NCT: NCT05469854 · CX842A2104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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