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

Cinclus Pharma Holding AB67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Safety Bioavailability Pharmacokinetics

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Relative Bioavailability of Linaprazan Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratios of AUCinf and AUClast

The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprazan, comparing test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan exposure is increased or decreased with the new formulation.