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

Phase 1

Recruiting

• Conditions: Cardiodynamic ECG; Pharmacokinetics; Safety, and Tolerability; GERD
• Interventions: Drug: Placebo; Drug: Linaprazan glurate

• Registration Number: NCT05469854
• Lead Sponsor: Cinclus Pharma AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-13
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12-02
• Study Completion: 2024-12-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral administration as a singel dose
Linaprazan glurate	Linaprazan glurate	Oral administration as a single dose of 300 mg, 600 mg, 200 mg, and a final dose level of maximum 400 mg.

Primary Outcome Measures

Name	Time	Method
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)	Up to 24 hours	To assess the AUC from time 0 to the last measurable concentration (AUClast)
Measurement of Cardiodynamic ECG (QTcF)	Up to 24 hours	To assess the change from baseline in QTcF
Measurement of Cardiodynamic ECG (PR interval)	Up to 24 hours	To assess the change from baseline in PR interval
Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)	Up to 24 hours	To assess the change from baseline in placebo-corrected QRS interval
Measurement of Cardiodynamic ECG (changes of T-wave)	Up to 24 hours	Frequency of treatment emergent changes of T-wave abnormalities
Measurement of Cardiodynamic ECG (placebo-corrected PR interval)	Up to 24 hours	To assess the change from baseline in placebo-corrected PR interval
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)	Up to 24 hours	To assess the Maximum plasma concentration (Cmax)
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)	Up to 24 hours	To assess the Terminal elimination half-life (T1/2)
Measurement of Cardiodynamic ECG (placebo-corrected QTcF)	Up to 24 hours	To assess the change from baseline in placebo-corrected QTcF
Measurement of Cardiodynamic ECG (placebo-corrected heart rate)	Up to 24 hours	To assess the change from baseline in placebo-corrected heart rate
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)	Up to 24 hours	To assess the Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (AUCinf)
Measurement of Cardiodynamic ECG (heart rate)	Up to 24 hours	To assess the change from baseline in heart rate
Measurement of Cardiodynamic ECG (QRS interval)	Up to 24 hours	To assess the change from baseline in QRS interval
Measurement of Cardiodynamic ECG (categorical outliers)	Up to 24 hours	Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval)
Measurement of Cardiodynamic ECG (changes of U-wave)	Up to 24 hours	Frequency of treatment emergent changes of U-wave abnormalities

Trial Locations

Locations (1)

CTC Clinical Trial Consultants AB; 🇸🇪 Uppsala, Sweden