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

NCT05469854 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2024-02-07

No results posted yet for this study

Summary

This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized study designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of 2 single ascending oral doses of linaprazan glurate. The study 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, 600 mg, 200 mg and a final dose level of maximum 400 mg) of linaprazan glurate, using 25 mg base formulation (300 mg and 600 mg doses) and 25 mg and 100 mg HCl formulation (200 mg and final dose level of maximum 400 mg) oral tablets.

Conditions

  • Pharmacokinetics
  • Cardiodynamic ECG
  • Safety, and Tolerability
  • GERD

Interventions

DRUG

Linaprazan glurate

Linaprazan glurate base formulation, 25 mg oral tablets (300 mg and 600 mg doses). Linaprazan glurate hydrochloride (HCl), 25 mg and 100 mg (as base) oral tablets (200 mg and final dose level of maximum 400 mg).

DRUG

Placebo

Single dose, oral tablets

Sponsors & Collaborators

  • Cinclus Pharma AG

    lead INDUSTRY

Principal Investigators

  • Erik Rein-Hedin, MD · CTC Clinical Trial Consultants AB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2024-12-02
Completion
2024-12-02

Countries

  • Sweden

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469854 on ClinicalTrials.gov