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

Cinclus Pharma

Status and phase: Completed; Phase 1

Conditions: Bioavailability; Pharmacokinetics; Safety

Treatments: Drug: Linaprazan glurate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05627518

CX842A2106

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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67 participants in 3 patient groups

Reference formulation (Treatment A)

Active Comparator group

Description:

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

Treatment:

Drug: Linaprazan glurate

Test formulation (Treatment B)

Experimental group

Description:

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

Treatment:

Drug: Linaprazan glurate

Test Formulation (Treatment C)

Experimental group

Description:

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

Treatment:

Drug: Linaprazan glurate