A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCinclus Pharma Holding AB
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Linaprazan glurate
DrugLinaprazan 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).
Placebo
DrugSingle dose, oral tablets
Treatment groups
121 Participants
are divided into 2 treatment groupsGroup A: Linaprazan glurateExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)
To assess the Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (AUCinf)
Time frame
Up to 24 hours2
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)
To assess the AUC from time 0 to the last measurable concentration (AUClast)
Time frame
Up to 24 hours3
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)
To assess the Maximum plasma concentration (Cmax)
Time frame
Up to 24 hours4
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)
To assess the Terminal elimination half-life (T1/2)
Time frame
Up to 24 hoursSponsors and contacts
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Source ClinicalTrials.gov