A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate

Cinclus Pharma

Status and phase: Enrolling; Phase 1

Conditions: Safety, and Tolerability; Cardiodynamic ECG; GERD; Pharmacokinetics

Treatments: Drug: Placebo; Drug: Linaprazan glurate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05469854

CX842A2104

Details and patient eligibility

About

This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized trial designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of single oral doses of linaprazan glurate. The trial will explore the PK properties of linaprazan glurate and linaprazan as well as the cardiodynamic ECG effects, safety, and tolerability after the administration of single doses: 300 mg and 600 mg in Part I of the trial, using formulation A of linaprazan glurate, as well as 150 mg, 275 mg, and up to 2 additional dose levels, using formulation C of linaprazan glurate to reach target linaprazan mean Cmax exposure (5222 nmol/L).

Enrollment: 121 estimated 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
3. Body mass index ≥18.5 and ≤35.0 kg/m2.
4. Prospective subjects, as well as their partners, must agree to contraception requirements

Main 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: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 2 patient groups, including a placebo group

Linaprazan glurate

Experimental group

Description:

Oral administration as a single dose of 300 mg, 600 mg, 150 mg, 275 mg, and up to 2 additional dose levels.

Treatment:

Drug: Linaprazan glurate

Placebo

Placebo Comparator group

Description:

Oral administration as a singel dose

Treatment:

Drug: Placebo