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

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).

NCT Number	NCT05469854
Lead Sponsor	Cinclus Pharma Holding AB
Conditions	Pharmacokinetics, Cardiodynamic ECG, Safety, and Tolerability, GERD
Enrollment	121 participants
Start Date	2022-07-13
Primary Completion	2026-11-30 (estimated)
Study Completion	2026-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-17