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

NCT05469854 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2026-06-17

No results posted yet for this study

Summary

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).

Conditions

  • GERD
  • Pharmacokinetics
  • Cardiodynamic ECG
  • Safety, and Tolerability

Interventions

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).

DRUG

Placebo

Single dose, oral tablets

Sponsors & Collaborators

  • Cinclus Pharma Holding AB

    lead INDUSTRY

Principal Investigators

  • Erik Rein-Hedin, MD · CTC Clinical Trial Consultants AB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Sweden

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469854 on ClinicalTrials.gov