RecruitingPhase 1

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

Sweden121 participantsStarted 2022-07-13

Plain-language 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).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)

Timeframe: Up to 24 hours

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)

Timeframe: Up to 24 hours

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)

Timeframe: Up to 24 hours

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)

Timeframe: Up to 24 hours

Measurement of Cardiodynamic ECG (QTcF)

Timeframe: Up to 24 hours

Measurement of Cardiodynamic ECG (heart rate)

Timeframe: Up to 24 hours

Measurement of Cardiodynamic ECG (PR interval)

Timeframe: Up to 24 hours

Trial details

NCT IDNCT05469854

SponsorCinclus Pharma Holding AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Sophie Leyman, MD

+32 470214020 sophie.leyman@cincluspharma.com

View on ClinicalTrials.gov More Pharmacokinetics trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

What they're measuring

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)

Timeframe: Up to 24 hours

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)

Timeframe: Up to 24 hours

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)

Timeframe: Up to 24 hours

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)

Timeframe: Up to 24 hours

Measurement of Cardiodynamic ECG (QTcF)

Timeframe: Up to 24 hours

Measurement of Cardiodynamic ECG (heart rate)

Timeframe: Up to 24 hours

Measurement of Cardiodynamic ECG (PR interval)

Timeframe: Up to 24 hours