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

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

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 Overview

• Status: Recruiting
• Conditions: GERD; Pharmacokinetics; Cardiodynamic ECG; Safety, and Tolerability
• Intervention / Treatment: Drug: Placebo; Drug: Linaprazan glurate

• Study Type: Interventional
• Enrollment (Estimated): 121
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kajsa Larsson, MD, PhD; Phone Number: +46 70 675 01 28; Email: kajsa.larsson@cincluspharma.com
• Study Contact Backup: Name: Sophie Leyman, MD; Phone Number: +32 470214020; Email: sophie.leyman@cincluspharma.com

Study Locations

• Sweden
  • Uppsala, Sweden, SE-75237
    • Recruiting
    • CTC Clinical Trial Consultants AB
    • Principal Investigator: Erik Rein-Hedin, MD
    • Contact: Kristina Ocklind; Phone Number: +4618303300; Email: kristina.ocklind@ctc-ab.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Oral administration as a singel dose	Drug: Placebo; Single dose, oral tablets
Experimental: Linaprazan glurate; Oral administration as a single dose of 300 mg, 600 mg, 150 mg, 275 mg, and up to 2 additional dose levels.	Drug: 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).; Other Names: X842

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Up to 24 hours
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)	To assess the Maximum plasma concentration (Cmax)	Up to 24 hours
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)	To assess the Terminal elimination half-life (T1/2)	Up to 24 hours
Measurement of Cardiodynamic ECG (QTcF)	To assess the change from baseline in QTcF	Up to 24 hours
Measurement of Cardiodynamic ECG (heart rate)	To assess the change from baseline in heart rate	Up to 24 hours
Measurement of Cardiodynamic ECG (PR interval)	To assess the change from baseline in PR interval	Up to 24 hours
Measurement of Cardiodynamic ECG (QRS interval)	To assess the change from baseline in QRS interval	Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected QTcF)	To assess the change from baseline in placebo-corrected QTcF	Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected heart rate)	To assess the change from baseline in placebo-corrected heart rate	Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected PR interval)	To assess the change from baseline in placebo-corrected PR interval	Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)	To assess the change from baseline in placebo-corrected QRS interval	Up to 24 hours
Measurement of Cardiodynamic ECG (categorical outliers)	Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval)	Up to 24 hours
Measurement of Cardiodynamic ECG (changes of T-wave)	Frequency of treatment emergent changes of T-wave abnormalities	Up to 24 hours
Measurement of Cardiodynamic ECG (changes of U-wave)	Frequency of treatment emergent changes of U-wave abnormalities	Up to 24 hours

Collaborators and Investigators

• Sponsor: Cinclus Pharma Holding AB
• Investigators: Principal Investigator: Erik Rein-Hedin, MD, CTC Clinical Trial Consultants AB

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: CX842A2104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No