NCT05469854

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

A Phase I Study to Investigate the Pharmacokinetics and ECG Effects of Two Single Ascending Doses of Linaprazan Glurate Given as Oral Tablets to Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (estimated)
• Sponsor: Cinclus Pharma AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized study designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of 2 single ascending oral doses of linaprazan glurate. The study 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, 600 mg, 200 mg and a final dose level of maximum 400 mg) of linaprazan glurate, using 25 mg base formulation (300 mg and 600 mg doses) and 25 mg and 100 mg HCl formulation (200 mg and final dose level of maximum 400 mg) oral tablets.

Conditions

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

Interventions

Type	Name	Description
DRUG	Linaprazan glurate	Linaprazan glurate base formulation, 25 mg oral tablets (300 mg and 600 mg doses). Linaprazan glurate hydrochloride (HCl), 25 mg and 100 mg (as base) oral tablets (200 mg and final dose level of maximum 400 mg).
DRUG	Placebo	Single dose, oral tablets

Timeline

• Start date: 2022-07-13
• Primary completion: 2024-12-02
• Completion: 2024-12-02
• First posted: 2022-07-22
• Last updated: 2024-02-07

Locations

1 site across 1 country: Sweden