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

NCT05469854 — Phase 1, Recruiting, 121 participants, Cinclus Pharma Holding AB

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

Registry	NCT05469854
Status	Recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: quadruple, basic science
Enrollment	121 (Estimated)
Sponsor	Cinclus Pharma Holding AB (Industry)
Conditions	Pharmacokinetics, Cardiodynamic ECG, Safety, and Tolerability, GERD
Interventions	Linaprazan glurate, Placebo (Drug)
Dates	start 2022-07-13, primary completion 2026-11-30 (estimated), completion 2026-11-30 (estimated), first posted 2022-07-22, last updated 2026-06-17
Locations	1 site in Sweden

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Linaprazan glurate	Experimental	Drug: Linaprazan glurate	Oral administration as a single dose of 300 mg, 600 mg, 150 mg, 275 mg, and up to 2 additional dose levels.
Placebo	Placebo comparator	Drug: Placebo	Oral administration as a singel dose

Linaprazan glurate (Drug), also known as X842: 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).
Placebo (Drug): Single dose, oral tablets

+Outcome measures

Primary outcomes

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 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 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 (QTcF) [Up to 24 hours]: To assess the change from baseline in QTcF
Measurement of Cardiodynamic ECG (heart rate) [Up to 24 hours]: To assess the change from baseline in heart rate
Measurement of Cardiodynamic ECG (PR interval) [Up to 24 hours]: To assess the change from baseline in PR interval
Measurement of Cardiodynamic ECG (QRS interval) [Up to 24 hours]: To assess the change from baseline in QRS interval
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 Cardiodynamic ECG (placebo-corrected PR interval) [Up to 24 hours]: To assess the change from baseline in placebo-corrected 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 (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 T-wave) [Up to 24 hours]: Frequency of treatment emergent changes of T-wave abnormalities
Measurement of Cardiodynamic ECG (changes of U-wave) [Up to 24 hours]: Frequency of treatment emergent changes of U-wave abnormalities

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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).

+Locations (1)

Facility	City	Country	Status
CTC Clinical Trial Consultants AB	Uppsala	Sweden	Recruiting

+Investigators

Erik Rein-Hedin, MD, Principal investigator, CTC Clinical Trial Consultants AB