Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05469854
PHASE1

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

Sponsor: Cinclus Pharma Holding AB

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

121

Start Date

2022-07-13

Completion Date

2026-11-30

Last Updated

2026-06-17

Healthy Volunteers

Yes

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

Locations (1)

CTC Clinical Trial Consultants AB

Uppsala, Sweden