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

June 15, 2026 updated by: Cinclus Pharma Holding AB

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Uppsala, Sweden, SE-75237
        • Recruiting
        • CTC Clinical Trial Consultants AB
        • Principal Investigator:
          • Erik Rein-Hedin, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Oral administration as a singel dose
Drug: Placebo
Single dose, oral tablets
Experimental: Linaprazan glurate
Oral administration as a single dose of 300 mg, 600 mg, 150 mg, 275 mg, and up to 2 additional dose levels.
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).

Other Names:
  • X842

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)
Time Frame: Up to 24 hours
To assess the Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (AUCinf)
Up to 24 hours
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)
Time Frame: Up to 24 hours
To assess the AUC from time 0 to the last measurable concentration (AUClast)
Up to 24 hours
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)
Time Frame: Up to 24 hours
To assess the Maximum plasma concentration (Cmax)
Up to 24 hours
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)
Time Frame: Up to 24 hours
To assess the Terminal elimination half-life (T1/2)
Up to 24 hours
Measurement of Cardiodynamic ECG (QTcF)
Time Frame: Up to 24 hours
To assess the change from baseline in QTcF
Up to 24 hours
Measurement of Cardiodynamic ECG (heart rate)
Time Frame: Up to 24 hours
To assess the change from baseline in heart rate
Up to 24 hours
Measurement of Cardiodynamic ECG (PR interval)
Time Frame: Up to 24 hours
To assess the change from baseline in PR interval
Up to 24 hours
Measurement of Cardiodynamic ECG (QRS interval)
Time Frame: Up to 24 hours
To assess the change from baseline in QRS interval
Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected QTcF)
Time Frame: Up to 24 hours
To assess the change from baseline in placebo-corrected QTcF
Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected heart rate)
Time Frame: Up to 24 hours
To assess the change from baseline in placebo-corrected heart rate
Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected PR interval)
Time Frame: Up to 24 hours
To assess the change from baseline in placebo-corrected PR interval
Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)
Time Frame: Up to 24 hours
To assess the change from baseline in placebo-corrected QRS interval
Up to 24 hours
Measurement of Cardiodynamic ECG (categorical outliers)
Time Frame: Up to 24 hours
Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval)
Up to 24 hours
Measurement of Cardiodynamic ECG (changes of T-wave)
Time Frame: Up to 24 hours
Frequency of treatment emergent changes of T-wave abnormalities
Up to 24 hours
Measurement of Cardiodynamic ECG (changes of U-wave)
Time Frame: Up to 24 hours
Frequency of treatment emergent changes of U-wave abnormalities
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cinclus Pharma Holding AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erik Rein-Hedin, MD, CTC Clinical Trial Consultants AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CX842A2104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings