A Phase 1 interventional study of Linaprazan glurate and Placebo in Pharmacokinetics, Cardiodynamic ECG and Safety, and Tolerability, sponsored by Cinclus Pharma Holding AB. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Cinclus Pharma Holding AB · Phase 1, Interventional, and Basic science
Among 24 studies in Gastroesophageal Reflux with a site in Sweden — 1 open to participants now, 1 under way, none of them phase 3. Gastroesophageal Reflux · Sweden.
Among the 24 studies in Gastroesophageal Reflux with a site in Sweden, this one is the 9th largest by planned enrollment of the 21 interventional ones, is the only one that started in 2022, is one of 8 in phase 1, and was the 23rd registered.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 121 is above the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →1 of the 24 studies in Gastroesophageal Reflux with a site in Sweden is open now, in 1 country. Each count lists the studies.
Of the 132 Gastroesophageal Reflux studies recruiting now, 56 (42%) set no upper age limit and 53 (40%) stop at 75 or younger; 22 take children under 18; 20 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →24 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 1 started in 2022.
Median enrollment 70 across the 21 interventional studies, 103 across the 3 observational. Of the 23 that completed or were terminated, 2 (9%) have results posted.
19 of 24 have an industry lead sponsor. The 6 most frequent:
Cinclus Pharma Holding AB is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Cinclus Pharma Holding AB has 6 studies filed under Gastroesophageal Reflux — fewer than ten, so there is no comparison to draw.
1 of the studies in Gastroesophageal Reflux with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05469854Cinclus Pharma Holding ABA Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate | 2026-11-30 |
Among the 24 studies in Gastroesophageal Reflux with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
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).
Main inclusion Criteria:
Main exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral administration as a single dose of 300 mg, 600 mg, 150 mg, 275 mg, and up to 2 additional dose levels.
Drug: Linaprazan glurate
Oral administration as a singel dose
Drug: Placebo
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).
Also known as: X842
Single dose, oral tablets
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 hours
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 hours
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)
To assess the Maximum plasma concentration (Cmax)
Time frame: Up to 24 hours
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 hours
Measurement of Cardiodynamic ECG (QTcF)
To assess the change from baseline in QTcF
Time frame: Up to 24 hours
Measurement of Cardiodynamic ECG (heart rate)
To assess the change from baseline in heart rate
Time frame: Up to 24 hours
Measurement of Cardiodynamic ECG (PR interval)
To assess the change from baseline in PR interval
Time frame: Up to 24 hours
Measurement of Cardiodynamic ECG (QRS interval)
To assess the change from baseline in QRS interval
Time frame: Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected QTcF)
To assess the change from baseline in placebo-corrected QTcF
Time frame: Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected heart rate)
To assess the change from baseline in placebo-corrected heart rate
Time frame: Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected PR interval)
To assess the change from baseline in placebo-corrected PR interval
Time frame: Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)
To assess the change from baseline in placebo-corrected QRS interval
Time frame: Up to 24 hours
Measurement of Cardiodynamic ECG (categorical outliers)
Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval)
Time frame: Up to 24 hours
Measurement of Cardiodynamic ECG (changes of T-wave)
Frequency of treatment emergent changes of T-wave abnormalities
Time frame: Up to 24 hours
Measurement of Cardiodynamic ECG (changes of U-wave)
Frequency of treatment emergent changes of U-wave abnormalities
Time frame: Up to 24 hours
Started Jul 2022 (actual). Primary completion is estimated for Nov 2026, 52 months after the start.
Of 28 industry-sponsored phase 1 interventional studies under Gastroesophageal Reflux, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 6. This study's planned 52 months is above that.
Counting every sponsor, half of 34 studies reached it within 4 months; a quarter within 2 and three quarters within 10.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Linaprazan glurate
Cinclus Pharma Holding AB