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

Sponsor
Cinclus Pharma AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05469854
Collaborator
(none)
63
1
2
2.1
29.5

Study Details

Study Description

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 300 mg and 600 mg doses of linaprazan glurate.

Condition or Disease Intervention/Treatment Phase
  • Drug: Linaprazan glurate
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Jul 13, 2022
Anticipated Primary Completion Date :
Sep 16, 2022
Anticipated Study Completion Date :
Sep 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Linaprazan glurate

Oral administration as a single dose of 300 mg or 600 mg

Drug: Linaprazan glurate
Oral tablet containing 25mg linaprazan glurate, an inhibitor of gastric H+, K+-ATPase by K+-competitive binding.
Other Names:
  • X842
  • Placebo Comparator: Placebo

    Oral administration as a singel dose

    Drug: Linaprazan glurate
    Oral tablet containing 25mg linaprazan glurate, an inhibitor of gastric H+, K+-ATPase by K+-competitive binding.
    Other Names:
  • X842
  • Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. 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)

    3. Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax) [Up to 24 hours]

      To assess the Maximum plasma concentration (Cmax)

    4. Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2) [Up to 24 hours]

      To assess the Terminal elimination half-life (T1/2)

    5. Measurement of Cardiodynamic ECG (QTcF) [Up to 24 hours]

      To assess the change from baseline in QTcF

    6. Measurement of Cardiodynamic ECG (heart rate) [Up to 24 hours]

      To assess the change from baseline in heart rate

    7. Measurement of Cardiodynamic ECG (PR interval) [Up to 24 hours]

      To assess the change from baseline in PR interval

    8. Measurement of Cardiodynamic ECG (QRS interval) [Up to 24 hours]

      To assess the change from baseline in QRS interval

    9. Measurement of Cardiodynamic ECG (placebo-corrected QTcF) [Up to 24 hours]

      To assess the change from baseline in placebo-corrected QTcF

    10. Measurement of Cardiodynamic ECG (placebo-corrected heart rate) [Up to 24 hours]

      To assess the change from baseline in placebo-corrected heart rate

    11. Measurement of Cardiodynamic ECG (placebo-corrected PR interval) [Up to 24 hours]

      To assess the change from baseline in placebo-corrected PR interval

    12. Measurement of Cardiodynamic ECG (placebo-corrected QRS interval) [Up to 24 hours]

      To assess the change from baseline in placebo-corrected QRS interval

    13. Measurement of Cardiodynamic ECG (categorical outliers) [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) [Up to 24 hours]

      Frequency of treatment emergent changes of T-wave abnormalities

    15. Measurement of Cardiodynamic ECG (changes of U-wave) [Up to 24 hours]

      Frequency of treatment emergent changes of U-wave abnormalities

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CTC Clinical Trial Consultants AB Uppsala Sweden SE-75237

    Sponsors and Collaborators

    • Cinclus Pharma AG

    Investigators

    • Principal Investigator: Jian Fransén, MD, CTC Clinical Trial Consultants AB

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cinclus Pharma AG
    ClinicalTrials.gov Identifier:
    NCT05469854
    Other Study ID Numbers:
    • CX842A2104
    First Posted:
    Jul 22, 2022
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 22, 2022