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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-01-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Safety Bioavailability Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Reference formulation (Treatment A)

100 mg linaprazan glurate reference formulation (4x25 mg oral tablets) in fasting conditions

Group Type ACTIVE_COMPARATOR

Linaprazan glurate

Intervention Type DRUG

100 mg

Test formulation (Treatment B)

100 mg linaprazan glurate test formulation (1x100 mg oral tablet) in fasting conditions

Group Type EXPERIMENTAL

Linaprazan glurate

Intervention Type DRUG

100 mg

Test Formulation (Treatment C)

100 mg linaprazan glurate test formulation (1x100 mg oral tablet) in fed conditions

Group Type EXPERIMENTAL

Linaprazan glurate

Intervention Type DRUG

100 mg

Interventions

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Linaprazan glurate

100 mg

Intervention Type DRUG

Other Intervention Names

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formerly X842

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes