> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-the-pharmacokinetics-and-ecg-effects-b40a6d1c-f593-455c-9ff9-60db6950d692 > Record changed: 2026-11-04 # A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate NCT05469854 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) Participants 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) Lead sponsor Cinclus Pharma Holding AB Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) Start date 2022-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Short title** A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Dates **Completion date** 2026-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **First posted** 2022-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Registry last updated** 2026-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Primary completion date** 2026-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Start date** 2022-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Size and sites **Participants** 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Planned participants** 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Lead sponsor** Cinclus Pharma Holding AB Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Identifiers **Registry ID** NCT05469854 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **ClinicalTrials.gov ID** NCT05469854 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Outcomes ### Primary outcomes 1. Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf) Timeframe: Up to 24 hours To assess the Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (AUCinf) 2. Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast) Timeframe: Up to 24 hours To assess the AUC from time 0 to the last measurable concentration (AUClast) 3. Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax) Timeframe: Up to 24 hours To assess the Maximum plasma concentration (Cmax) 4. Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2) Timeframe: Up to 24 hours To assess the Terminal elimination half-life (T1/2) 5. Measurement of Cardiodynamic ECG (QTcF) Timeframe: Up to 24 hours To assess the change from baseline in QTcF 6. Measurement of Cardiodynamic ECG (heart rate) Timeframe: Up to 24 hours To assess the change from baseline in heart rate 7. Measurement of Cardiodynamic ECG (PR interval) Timeframe: Up to 24 hours To assess the change from baseline in PR interval 8. Measurement of Cardiodynamic ECG (QRS interval) Timeframe: Up to 24 hours To assess the change from baseline in QRS interval 9. Measurement of Cardiodynamic ECG (placebo-corrected QTcF) Timeframe: Up to 24 hours To assess the change from baseline in placebo-corrected QTcF 10. Measurement of Cardiodynamic ECG (placebo-corrected heart rate) Timeframe: Up to 24 hours To assess the change from baseline in placebo-corrected heart rate 11. Measurement of Cardiodynamic ECG (placebo-corrected PR interval) Timeframe: Up to 24 hours To assess the change from baseline in placebo-corrected PR interval 12. Measurement of Cardiodynamic ECG (placebo-corrected QRS interval) Timeframe: Up to 24 hours To assess the change from baseline in placebo-corrected QRS interval 13. Measurement of Cardiodynamic ECG (categorical outliers) Timeframe: Up to 24 hours Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval) 14. Measurement of Cardiodynamic ECG (changes of T-wave) Timeframe: Up to 24 hours Frequency of treatment emergent changes of T-wave abnormalities 15. Measurement of Cardiodynamic ECG (changes of U-wave) Timeframe: Up to 24 hours Frequency of treatment emergent changes of U-wave abnormalities Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes Main inclusion Criteria: 1. Willing and able to give written informed consent for participation in the study. 2. Healthy male or female aged 18 to 65 years 3. Body mass index ≥18.5 and ≤35.0 kg/m2. 4. Prospective subjects, as well as their partners, must agree to contraception requirements Main exclusion criteria: 1. 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. 2. 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 3. History of or current clinically significant disease as defined in the protocol. 4. History of GERD, significant acid reflux. 5. 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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Sites - CTC Clinical Trial Consultants ABUppsala, SwedenRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469854) ## Related records ### Drugs (1) - [Linaprazan glurate](https://trialight.com/data/asset/linaprazan-glurate-404f09dc-48f6-4a46-a6c8-1e427bbbdcdf.md) ### Lead sponsors (1) - [Cinclus Pharma Holding AB](https://trialight.com/data/company/cinclus-pharma-holding-ab-583466bf-c73d-4c50-8846-7a8d2c116aef.md) ### Conditions (1) - [Gastroesophageal reflux disease](https://trialight.com/data/condition/gastroesophageal-reflux-disease-98b37c15-1154-58ee-9085-aa95708c220a.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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