RecruitingPhase 1NCT05469854

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

A Phase I Trial to Investigate the Pharmacokinetics and ECG Effects of Single Doses of Linaprazan Glurate Administered as Oral Tablets to Healthy Participants

Sponsor

Cinclus Pharma Holding AB

Enrollment

121 participants

Start Date

Jul 13, 2022

Study Type

INTERVENTIONAL

Conditions

Pharmacokinetics Cardiodynamic ECG Safety and Tolerability GERD

Summary

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).

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

Willing and able to give written informed consent for participation in the study.
Healthy male or female aged 18 to 65 years
Body mass index ≥18.5 and ≤35.0 kg/m2.
Prospective subjects, as well as their partners, must agree to contraception requirements

Exclusion Criteria5

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).

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Interventions

DRUGLinaprazan glurate

Linaprazan glurate base formulation, 25 mg oral tablets (300 mg and 600 mg doses). Linaprazan glurate hydrochloride (HCl), 25 mg and 50 mg (as base) oral tablets (150 mg, 275 mg and up to 2 additional dose levels).

DRUGPlacebo

Single dose, oral tablets