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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469854
• Other study ID #: CX842A2104
• Status: Recruiting
• Phase: Phase 1
• Start date: July 13, 2022
• Est. completion date: December 2, 2024

Study information

• Verified date: February 2024
• Source: Cinclus Pharma AG
• Contact: Simon Rubinstein, MD, PhD
• Phone: +44 786 780 70 60
• Email: simon.rubinstein[@]cincluspharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 113
• Est. completion date: December 2, 2024
• Est. primary completion date: December 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Main inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.

2. Healthy male or female aged 18 to 65 years

3. Body mass index =18.5 and =35.0 kg/m2.

4. Prospective subjects, as well as their partners, must agree to contraception requirements

Main exclusion criteria:

1. Female subjects of childbearing potential unless they agree to use highly effective methods of contraception (failure rate of <1%) from 2 weeks prior to dosing until the end-of-study visit.

2. Male subjects with a partner of childbearing potential, unless they agree to use method of contraception from 2 weeks prior to dosing until the end-of-study visit.History of or current clinically significant disease as defined in the protocol

3. History of or current clinically significant disease as defined in the protocol.

4. History of GERD, significant acid reflux.

5. Subjects who are pregnant, currently breastfeeding, or intend to become pregnant (female subjects) or father a child (male subjects) during the course of the study (i.e., from screening to end of study visit).

Related Conditions & MeSH terms

• GERD
• Pharmacokinetics

Intervention

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).
• Placebo
Single dose, oral tablets

Locations

Country	Name	City	State
Sweden	CTC Clinical Trial Consultants AB	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Cinclus Pharma AG

Country where clinical trial is conducted

Sweden, 

Outcome

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