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

Study Overview
=================
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.

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

Conditions
-----------------
Safety, Bioavailability, Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Linaprazan glurate


Participation Criteria
=================
Eligibility Criteria
-----------------
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, inclusive. Body mass index ≥18.5 and ≤30.0 kg/m2. Medically healthy, without abnormal clinically significant medical history Female subjects of childbearing potential, as well as their partners and male subjects and their partners, who agree to using methods of contraception Willing and able to consume the high-fat, high calorie breakfast 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference formulation (Treatment A)<br>100 mg linaprazan glurate reference formulation, fasting conditions | Drug: Linaprazan glurate<br>* 100 mg<br>* Other names: formerly X842;|
| Experimental: Test formulation (Treatment B)<br>100 mg linaprazan glurate reference formulation, fasting conditions | Drug: Linaprazan glurate<br>* 100 mg<br>* Other names: formerly X842;|
| Experimental: Test Formulation (Treatment C)<br>100 mg linaprazan glurate test formulation, fed conditions | Drug: Linaprazan glurate<br>* 100 mg<br>* Other names: formerly X842;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf) | Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (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 | 
| Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast) | AUC from time 0 to the last measurable concentration (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 | 
| Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax) | Maximum plasma concentration (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 |