UnknownPhase 1

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

Sweden113 participantsStarted 2022-07-13

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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
✕. History of or current clinically significant disease as defined in the protocol.
✕. History of GERD, significant acid reflux.
✕

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

Measurement of Cardiodynamic ECG (QRS interval)

Timeframe: Up to 24 hours

Trial details

NCT IDNCT05469854

SponsorCinclus Pharma AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-02

Contact for this trial

Simon Rubinstein, MD, PhD

+44 786 780 70 60 simon.rubinstein@cincluspharma.com

View on ClinicalTrials.gov More Pharmacokinetics trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

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
✕. History of or current clinically significant disease as defined in the protocol.
✕. History of GERD, significant acid reflux.
✕

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

Measurement of Cardiodynamic ECG (QRS interval)

Timeframe: Up to 24 hours