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NCT Number: NCT05469854

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

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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Key information

Conditions

Pharmacokinetics Cardiodynamic ECG Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders GERD Gastroesophageal Reflux Gastrointestinal Diseases Safety, and Tolerability

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CTC Clinical Trial Consultants AB

Uppsala, SE-75237, Sweden

Location status: Recruiting

Location contact

Erik Rein-Hedin, MD

PRINCIPAL_INVESTIGATOR

Kristina Ocklind

CONTACT

[email protected]

+4618303300

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main inclusion Criteria:

  • Willing and able to give written informed consent for participation in the study.
  • Healthy male or female aged 18 to 65 years
  • Body mass index ≥18.5 and ≤35.0 kg/m2.
  • Prospective subjects, as well as their partners, must agree to contraception requirements

Main exclusion criteria:

  • 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.
  • 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
  • History of or current clinically significant disease as defined in the protocol.
  • History of GERD, significant acid reflux.
  • 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).

Treatment and study plan

Linaprazan glurate

Drug

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

Placebo

Drug

Single dose, oral tablets

Primary outcomes

  1. 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)

  2. 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)

  3. Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)

    Time frame: Up to 24 hours

    To assess the Maximum plasma concentration (Cmax)

  4. 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)

  5. Measurement of Cardiodynamic ECG (QTcF)

    Time frame: Up to 24 hours

    To assess the change from baseline in QTcF

  6. Measurement of Cardiodynamic ECG (heart rate)

    Time frame: Up to 24 hours

    To assess the change from baseline in heart rate

  7. Measurement of Cardiodynamic ECG (PR interval)

    Time frame: Up to 24 hours

    To assess the change from baseline in PR interval

  8. Measurement of Cardiodynamic ECG (QRS interval)

    Time frame: Up to 24 hours

    To assess the change from baseline in QRS interval

  9. Measurement of Cardiodynamic ECG (placebo-corrected QTcF)

    Time frame: Up to 24 hours

    To assess the change from baseline in placebo-corrected QTcF

  10. 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

  11. 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

  12. 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

  13. 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)

  14. Measurement of Cardiodynamic ECG (changes of T-wave)

    Time frame: Up to 24 hours

    Frequency of treatment emergent changes of T-wave abnormalities

  15. Measurement of Cardiodynamic ECG (changes of U-wave)

    Time frame: Up to 24 hours

    Frequency of treatment emergent changes of U-wave abnormalities

Study contacts

Contact information is provided by the study sponsor or research team.

Kajsa Larsson, MD, PhD

CONTACT

[email protected]

+46 70 675 01 28

Sophie Leyman, MD

CONTACT

[email protected]

+32 470214020

Sponsors and collaborators

Lead sponsor

Cinclus Pharma Holding AB

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2022
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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