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BA: Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation

Sponsor
Cinclus Pharma AG (Industry)
Overall Status
Completed
CT.gov ID
NCT05627518
Collaborator
(none)
54
Enrollment
1
Location
3
Arms
1.6
Actual Duration (Months)
34.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a previously studied oral tablet formulation under fasting conditions, and to assess the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan after the administration of the new oral tablet formulation.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Single Dose, Crossover Study in Healthy Volunteers to Investigate the Relative Bioavailability of Linaprazan for a New Oral Tablet Formulation of Linaprazan Glurate, and to Assess the Effect of Food on the Pharmacokinetics of Linaprazan
Actual Study Start Date :
Nov 15, 2022
Actual Primary Completion Date :
Dec 30, 2022
Actual Study Completion Date :
Jan 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Reference formulation (Treatment A)

100 mg linaprazan glurate reference formulation, fasting conditions

Drug: Linaprazan glurate
100 mg
Other Names:
  • formerly X842

    		•
    Experimental: Test formulation (Treatment B)

    100 mg linaprazan glurate reference formulation, fasting conditions

    Drug: Linaprazan glurate
    100 mg
    Other Names:
  • formerly X842

    		•
    Experimental: Test Formulation (Treatment C)

    100 mg linaprazan glurate test formulation, fed conditions

    Drug: Linaprazan glurate
    100 mg
    Other Names:
  • formerly X842

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf) [pre dose, 0,25h, 0,5h, 1h, 1,25h, 1,5h, 2h, 3h, 4h, 6h, 8h, 12h, 14h, 20h, 24h, 36h, 48h and 72 h post dose]

      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) [pre dose, 0,25h, 0,5h, 1h, 1,25h, 1,5h, 2h, 3h, 4h, 6h, 8h, 12h, 14h, 20h, 24h, 36h, 48h and 72 h post dose]

      AUC from time 0 to the last measurable concentration (AUClast)

    3. Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax) [pre dose, 0,25h, 0,5h, 1h, 1,25h, 1,5h, 2h, 3h, 4h, 6h, 8h, 12h, 14h, 20h, 24h, 36h, 48h and 72 h post dose]

      Maximum plasma concentration (Cmax)

    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, inclusive.

    3. Body mass index ≥18.5 and ≤30.0 kg/m2.

    4. Medically healthy, without abnormal clinically significant medical history

    5. Female subjects of childbearing potential, as well as their partners and male subjects and their partners, who agree to using methods of contraception

    6. Willing and able to consume the high-fat, high calorie breakfast

    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 CRS d.o.o. Ljubljana Ukmarjeva Ulica 6 Slovenia 1000

    Sponsors and Collaborators

    • Cinclus Pharma AG

    Investigators

    • Study Director: Tanja Turk, M. Pharm, CRS d.o.o.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cinclus Pharma AG
    ClinicalTrials.gov Identifier:
    NCT05627518
    Other Study ID Numbers:
    • CX842A2106
    First Posted:
    Nov 25, 2022
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes

    Study Results

    No Results Posted as of Jan 18, 2023