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

Phase 1RecruitingNCT05469854

Cinclus Pharma Holding AB121 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

121

Conditions

Pharmacokinetics Cardiodynamic ECG Safety, and Tolerability GERD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Main inclusion Criteria: 1. Willing and able to give written informed consent for participation in the study. 2. Healthy male or female aged 18 to 65 years 3. Body mass index ≥18.5 and ≤35.0 kg/m2. 4. Prospective subjects, as well as their partners, must agree to contraception requirements Main exclusion criteria: 1. 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. 2. 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 3. History of or current clinically significant disease as defined in the protocol. 4. History of GERD, significant acid reflux. 5. 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).

Outcomes

Primary Outcomes

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)

To assess the Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (AUCinf)

Time frame: Up to 24 hours

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)

To assess the AUC from time 0 to the last measurable concentration (AUClast)

Time frame: Up to 24 hours

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)

To assess the Maximum plasma concentration (Cmax)

Time frame: Up to 24 hours

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)

To assess the Terminal elimination half-life (T1/2)

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (QTcF)

To assess the change from baseline in QTcF

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (heart rate)

To assess the change from baseline in heart rate

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (PR interval)

To assess the change from baseline in PR interval

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (QRS interval)

To assess the change from baseline in QRS interval

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (placebo-corrected QTcF)

To assess the change from baseline in placebo-corrected QTcF

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (placebo-corrected heart rate)

To assess the change from baseline in placebo-corrected heart rate

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (placebo-corrected PR interval)

To assess the change from baseline in placebo-corrected PR interval

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)

To assess the change from baseline in placebo-corrected QRS interval

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (categorical outliers)

Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval)

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (changes of T-wave)

Frequency of treatment emergent changes of T-wave abnormalities

Time frame: Up to 24 hours

Measurement of Cardiodynamic ECG (changes of U-wave)

Frequency of treatment emergent changes of U-wave abnormalities

Time frame: Up to 24 hours

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts