A Phase 1 interventional study of Drug Drug Interaction in Drug Interaction, GERD (Gastroesophageal Reflux Disease) and Safety, and Tolerability, sponsored by Cinclus Pharma Holding AB. Completed at 1 site in Sweden. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Cinclus Pharma Holding AB · Phase 1, Interventional, and Treatment
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 21st largest by enrollment of the 21 interventional ones, is the only one that started in 2025, is one of 8 in phase 1, and was the 24th registered.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's enrollment of 12 is below 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 64 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 2025.
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 an open, single arm, single-center Phase I trial designed to evaluate the effect of seven days repeated oral doses of linaprazan glurate on the pharmacokinetics (PK) of repeated doses of amoxicillin in healthy male and female participants
Participants in the trial will attend three visits to the clinical research unit (CRU) and a telephone follow-up visit.
Eligible participants will be admitted to the CRU in the evening of Day -1 and will remain at the CRU until the morning of Day 2 In the morning of Day 1, after pre-dose assessments, a dose of amoxicillin will be administered followed by 24 hours PK blood sampling for determination of amoxicillin plasma concentrations. Safety will be followed up throughout the 24 hours. In the morning of Day 2, after the 24-hour amoxicillin PK sample and safety assessments, the first linaprazan glurate will be administered to the participants. The participants will then continue to take linaprazan glurate (Day 2 to Day 8).
The participants will be admitted to the CRU in the afternoon of Day 6 and will remain at the CRU until the morning of Day 9. PK samples for determination of linaprazan glurate and linaprazan in plasma will be collected for 24 hours at Day 7. In the morning of Day 8, the participants will be administered a new dose of amoxicillin together with the dose of linaprazan glurate, which will be followed by 24 hours PK sampling for determination of amoxicillin, linaprazan glurate and linaprazan plasma concentrations. The participants will leave the CRU after the 24-hour PK sample and safety assessments.
A final end-of-trial telephone call will take place seven days (±two days) after the final dosing on Day 8.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Female participants of (defined as all participants physiologically capable of becoming pregnant) unless they agree to use one of the following highly effective methods of (failure rate of \<1%) from 2 weeks prior to the first dose until the end-of-trial visit:
Male participants with a partner of childbearing potential, unless they agree to use one of the following methods of contraception from two weeks prior to the first dose until the end-of-trial visit:
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Oral administration for seven (7) days.
Drug: Drug Drug Interaction
The intervention phase consists of 2 periods: in period 1, the pharmacokinetics (PK) of amoxicillin will be evaluated in the absence of linaprazan glurate, in period 2, a potential effect of linaprazan glurate on the PK of amoxicillin will be evaluated as well as the PK of linaprazan glurate following co-administration of amoxicillin.
Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (AUC)
Geometric mean ratio Day 8/Day 1 for amoxicillin Area Under the Plasma Concentration vs. Time Curve (AUC)
Time frame: Day 1 and Day 8
Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (Cmax)
Geometric mean ratio Day 8/Day 1 for amoxicillin Cmax
Time frame: Day 1 and Day 8
Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (Tmax)
Amoxicillin Tmax
Time frame: Day 1 and Day 8
Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (CL/F)
Amoxicillin apparent oral clearance (CL/F)
Time frame: Day 1 and Day 8
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2025 to primary completion in Dec 2025, 1 month.
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 1 month is below 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.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Cinclus Pharma Holding AB