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Recruiting NCT05469854

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

Phase I Interventional Pharmacokinetics Cardiodynamic ECG Safety, and Tolerability GERD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Linaprazan glurate, Placebo.
Who it may be relevant to
Registry conditions: Pharmacokinetics, Cardiodynamic ECG, Safety, and Tolerability, GERD. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

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 50 mg (as base) oral tablets (150 mg, 275 mg and up to 2 additional dose levels).
  • Drug Placebo
    Single dose, oral tablets

Primary outcome measures

  • Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf) [Time frame: Up to 24 hours]
  • Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast) [Time frame: Up to 24 hours]
  • Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax) [Time frame: Up to 24 hours]
  • Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2) [Time frame: Up to 24 hours]
  • Measurement of Cardiodynamic ECG (QTcF) [Time frame: Up to 24 hours]
  • Measurement of Cardiodynamic ECG (heart rate) [Time frame: Up to 24 hours]
  • Measurement of Cardiodynamic ECG (PR interval) [Time frame: Up to 24 hours]
  • Measurement of Cardiodynamic ECG (QRS interval) [Time frame: Up to 24 hours]
  • Measurement of Cardiodynamic ECG (placebo-corrected QTcF) [Time frame: Up to 24 hours]
  • Measurement of Cardiodynamic ECG (placebo-corrected heart rate) [Time frame: Up to 24 hours]

Eligibility criteria

Main inclusion Criteria:

  • 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

Main exclusion criteria:

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

Sweden · 1 center
  • CTC Clinical Trial Consultants AB — Uppsala

Identifiers

NCT: NCT05469854 · CX842A2104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗