GERDPhase 1NCT05742984

Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects

A Phase 1 study testing linaprazan glurate 25 mg QD, linaprazan glurate 50 mg QD and linaprazan glurate 75 mg QD in people with GERD, run by Cinclus Pharma Holding AB at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase I, single-center, open label parallel-group, randomized study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD, by continuous intragastric pH measurment), safety and tolerability of single and repeated oral doses of linaprazan glurate in 3 different dose levels given once- (QD) or… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: GERD
What is being tested?: linaprazan glurate 25 mg QD, linaprazan glurate 50 mg QD and linaprazan glurate 75 mg QD
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteSlovenia
Study dates: 26 Jan 2023to 13 Apr 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Willing and able to give written informed consent for participation in the study.
Healthy male or female subject aged 18 to 65 years, inclusive.
Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
Medically healthy, without abnormal clinically significant medical history, physical findings, vital signs, ECGs, or laboratory values at the time of screening, as judged by the Investigator.

Who cannot join

Female subjects of childbearing potential (defined as all subjects physiologically capable of becoming pregnant)
Male subjects with a partner of childbearing potential
History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History of GERD or clinically significant acid reflux, as judged by the Investigator.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

CRS d.o.o,Ukmarjeva ulica 6
Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Phase 1, Open Label, Randomized, Parallel-group, Single Center Study to Investigate Pharmacokinetics and Pharmacodynamics (Intragastric pH) of Linaprazan Glurate/Linaprazan After Single and 14 Days'Repeated Oral Administration of Linaprazan Glurate to Healthy Subjects

The subjects will be followed up to 28 days post IMP dosing.

Conditions: GERD
Being tested: linaprazan glurate 25 mg QD, linaprazan glurate 50 mg QD, linaprazan glurate 75 mg QD, linaprazan glurate 25 mg BID, linaprazan glurate 50 mg BID
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

linaprazan glurate 25 mg QDDrug
The subjects will receive 25 mg dose in the evening, in a non-fasted condition 30 minutes after the evening meal, for 14 days. Subjects are to follow a standardized food intake schedule.
After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more in the evening (non-fasted).
linaprazan glurate 50 mg QDDrug
The subjects will receive 50 mg dose in the evening, in a non-fasted condition 30 minutes after the evening meal, for 14 days. Subjects are to follow a standardized food intake schedule.
After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more in the evening (non-fasted).
linaprazan glurate 75 mg QDDrug
The subjects will receive 75 mg dose in the evening, in a non-fasted condition 30 minutes after the evening meal, for 14 days. Subjects are to follow a standardized food intake schedule.
After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more in the evening (non-fasted).
linaprazan glurate 25 mg BIDDrug
The subjects will receive 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects will be fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, are allowed as desired, except for 1 hour before and 30 minutes after dosing. The second daily dose will be administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more (in fasted condition in the morning, non-fasted in the evening).
linaprazan glurate 50 mg BIDDrug
The subjects will receive 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects will be fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, are allowed as desired, except for 1 hour before and 30 minutes after dosing. The second daily dose will be administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more (in fasted condition in the morning, non-fasted in the evening).
linaprazan glurate 75 mg BIDDrug
The subjects will receive 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects will be fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, are allowed as desired, except for 1 hour before and 30 minutes after dosing. The second daily dose will be administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more (in fasted condition in the morning, non-fasted in the evening).

Study groups in NCT05742984
Study group	Role	What they receive
Group 1: 25 mg linaprazan glurate QD	Experimental	25 mg (one 25 mg oral tablet) linaprazan glurate once daily (QD) for 14 days Receives: Drug: linaprazan glurate 25 mg QD
Group 2: 50 mg Linaprazan Glurate QD	Experimental	50 mg (two 25 mg oral tablets) linaprazan glurate once daily (QD) for 14 days Receives: Drug: linaprazan glurate 50 mg QD
Group 3: 75 mg Linaprazan Glurate QD	Experimental	75 mg (three 25 mg oral tablet) linaprazan glurate once daily (QD) for 14 days Receives: Drug: linaprazan glurate 75 mg QD
Group 4: 25 mg Linaprazan Glurate BID	Experimental	25 mg (one 25mg oral tablet) linaprazan glurate twice daily (BID) for 14 days Receives: Drug: linaprazan glurate 25 mg BID
Group 5: 50 mg Linaprazan Glurate BID	Experimental	50 mg (two 25 mg oral tablets) linaprazan glurate twice daily (BID) for 14 days Receives: Drug: linaprazan glurate 50 mg BID
Group 6: 75 mg Linaprazan Glurate BID	Experimental	75 mg (three 25 mg oral tablet) linaprazan glurate twice daily (BID) for 14 days Receives: Drug: linaprazan glurate 75 mg BID

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC0-24h Linaprazan (QD)
Linaprazan area under the plasma concentration curve, from 0 to 24h post dose on Day 1 and Day 14. QD groups only.
Measured: Day 1 and Day 14
AUC0-12, 12-24h Linaprazan (BID)
Linaprazan area under the plasma concentration curve, from 0 to 12h and 12-24h post dose on Day 1 and Day 14. BID groups only.
Measured: Day 1 and Day 14
Cmax Linaprazan (QD)
Linaprazan maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.
Measured: Day 1 and day 14
Cmax Linaprazan (BID)
Linaprazan maximum plasma concentration 0-12h, and 12-24h post dose for BID groups, at day 1 and day 14.
Measured: Day 1 and day 14
AUC0-24h Linaprazan Glurate (QD)
Linaprazan glurate area under the plasma concentration curve, from 0-24h post dose on Day 1 and Day 14. QD groups only.
Measured: Day 1 and day 14
AUC0-12h, 12-24h Linaprazan Glurate (BID)
Linaprazan glurate area under the plasma concentration curve, from 0 to 12h and 12-24h post dose on Day 1 and Day 14. BID groups only.
Measured: Day 1 and Day 14
Cmax Linaprazan Glurate (QD)
Linaprazan glurate maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.
Measured: Day 1 and day 14
Cmax Linaprazan Glurate (BID)
Linaprazan glurate maximum plasma concentration 0-12h and 12-24h post dose for BID groups, at day 1 and day 14.
Measured: Day 1 and day 14
Percentage of Time Gastric pH >4 Over a 24-hour Monitoring Period (Holding Time Ratio, HTR)
Percentage of time gastric pH >4 at Days 1 and 14 over a 24-hour monitoring period following linaprazan glurate administration.
Intragastric pH was measured every second with an intragastric probe. The measurements were compressed into 10-minute median intervalls before calculating the % of time with intragastric >pH 4 (HTR). The HTR is presented with descriptive statistics, by dosing group.
Measured: Day 1 and day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 202313 Apr 2023

First posted24 Feb 2023
Study start26 Jan 2023
Primary completion24 Mar 2023
Study completion13 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GERDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05742984
Sponsor's protocol ID: CX842A2107
Status last verified: May 2025
First submitted: 2 Jan 2023
Last updated: 7 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

All GERD trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open Label, Randomized, Parallel-group, Single Center Study to Investigate Pharmacokinetics and Pharmacodynamics (Intragastric pH) of Linaprazan Glurate/Linaprazan After Single and 14 Days'Repeated Oral Administration of Linaprazan Glurate to Healthy Subjects
ClinicalTrials.gov ID: NCT05742984
Acronym / sponsor ID: CX842A2107
Conditions: GERD
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Cinclus Pharma Holding ABIndustry (pharma, biotech, devices)
Study start: 26 Jan 2023 (actual)
Primary completion: 24 Mar 2023 (actual)
Study completion: 13 Apr 2023 (actual)
First posted: 24 Feb 2023 (actual)
Results: Posted 7 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The subjects will be followed up to 28 days post IMP dosing.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Group 1: 25 mg linaprazan glurate QD	Experimental	Drug: linaprazan glurate 25 mg QD25 mg (one 25 mg oral tablet) linaprazan glurate once daily (QD) for 14 days
Group 2: 50 mg Linaprazan Glurate QD	Experimental	Drug: linaprazan glurate 50 mg QD50 mg (two 25 mg oral tablets) linaprazan glurate once daily (QD) for 14 days
Group 3: 75 mg Linaprazan Glurate QD	Experimental	Drug: linaprazan glurate 75 mg QD75 mg (three 25 mg oral tablet) linaprazan glurate once daily (QD) for 14 days
Group 4: 25 mg Linaprazan Glurate BID	Experimental	Drug: linaprazan glurate 25 mg BID25 mg (one 25mg oral tablet) linaprazan glurate twice daily (BID) for 14 days
Group 5: 50 mg Linaprazan Glurate BID	Experimental	Drug: linaprazan glurate 50 mg BID50 mg (two 25 mg oral tablets) linaprazan glurate twice daily (BID) for 14 days
Group 6: 75 mg Linaprazan Glurate BID	Experimental	Drug: linaprazan glurate 75 mg BID75 mg (three 25 mg oral tablet) linaprazan glurate twice daily (BID) for 14 days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Willing and able to give written informed consent for participation in the study.
Healthy male or female subject aged 18 to 65 years, inclusive.
Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
Medically healthy, without abnormal clinically significant medical history, physical findings, vital signs, ECGs, or laboratory values at the time of screening, as judged by the Investigator.

Key exclusion criteria (4 listed)

Female subjects of childbearing potential (defined as all subjects physiologically capable of becoming pregnant)
Male subjects with a partner of childbearing potential
History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History of GERD or clinically significant acid reflux, as judged by the Investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
linaprazan glurate 25 mg QDThe subjects will receive 25 mg dose in the evening, in a non-fasted condition 30 minutes after the evening meal, for 14 days. Subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more in the evening (non-fasted).	Drug	Group 1: 25 mg linaprazan glurate QD
linaprazan glurate 50 mg QDThe subjects will receive 50 mg dose in the evening, in a non-fasted condition 30 minutes after the evening meal, for 14 days. Subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more in the evening (non-fasted).	Drug	Group 2: 50 mg Linaprazan Glurate QD
linaprazan glurate 75 mg QDThe subjects will receive 75 mg dose in the evening, in a non-fasted condition 30 minutes after the evening meal, for 14 days. Subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more in the evening (non-fasted).	Drug	Group 3: 75 mg Linaprazan Glurate QD
linaprazan glurate 25 mg BIDThe subjects will receive 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects will be fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, are allowed as desired, except for 1 hour before and 30 minutes after dosing. The second daily dose will be administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more (in fasted condition in the morning, non-fasted in the evening).	Drug	Group 4: 25 mg Linaprazan Glurate BID
linaprazan glurate 50 mg BIDThe subjects will receive 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects will be fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, are allowed as desired, except for 1 hour before and 30 minutes after dosing. The second daily dose will be administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more (in fasted condition in the morning, non-fasted in the evening).	Drug	Group 5: 50 mg Linaprazan Glurate BID
linaprazan glurate 75 mg BIDThe subjects will receive 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects will be fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, are allowed as desired, except for 1 hour before and 30 minutes after dosing. The second daily dose will be administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more (in fasted condition in the morning, non-fasted in the evening).	Drug	Group 6: 75 mg Linaprazan Glurate BID

Primary outcome

AUC0-24h Linaprazan (QD)
Time frame: Day 1 and Day 14
Linaprazan area under the plasma concentration curve, from 0 to 24h post dose on Day 1 and Day 14. QD groups only.
AUC0-12, 12-24h Linaprazan (BID)
Time frame: Day 1 and Day 14
Linaprazan area under the plasma concentration curve, from 0 to 12h and 12-24h post dose on Day 1 and Day 14. BID groups only.
Cmax Linaprazan (QD)
Time frame: Day 1 and day 14
Linaprazan maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.
Cmax Linaprazan (BID)
Time frame: Day 1 and day 14
Linaprazan maximum plasma concentration 0-12h, and 12-24h post dose for BID groups, at day 1 and day 14.
AUC0-24h Linaprazan Glurate (QD)
Time frame: Day 1 and day 14
Linaprazan glurate area under the plasma concentration curve, from 0-24h post dose on Day 1 and Day 14. QD groups only.
AUC0-12h, 12-24h Linaprazan Glurate (BID)
Time frame: Day 1 and Day 14
Linaprazan glurate area under the plasma concentration curve, from 0 to 12h and 12-24h post dose on Day 1 and Day 14. BID groups only.
Cmax Linaprazan Glurate (QD)
Time frame: Day 1 and day 14
Linaprazan glurate maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.
Cmax Linaprazan Glurate (BID)
Time frame: Day 1 and day 14
Linaprazan glurate maximum plasma concentration 0-12h and 12-24h post dose for BID groups, at day 1 and day 14.
Percentage of Time Gastric pH >4 Over a 24-hour Monitoring Period (Holding Time Ratio, HTR)
Time frame: Day 1 and day 14
Percentage of time gastric pH >4 at Days 1 and 14 over a 24-hour monitoring period following linaprazan glurate administration. Intragastric pH was measured every second with an intragastric probe. The measurements were compressed into 10-minute median intervalls before calculating the % of time with intragastric >pH 4 (HTR). The HTR is presented with descriptive statistics, by dosing group.

Results and safety

Results posted to the registry on 7 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
25 mg Linaprazan Glurate QD	12	12
50 mg Linaprazan Glurate QD	13	12
75 mg Linaprazan Glurate QD	13	12
25 mg Linaprazan Glurate BID	12	12
50 mg Linaprazan Glurate BID	12	11
75 mg Linaprazan Glurate BID	13	10

Primary outcome: AUC0-24h Linaprazan (QD)

Time frame: Day 1 and Day 14. Mean (Standard Deviation). Unit: nmol/L*h

Measure	25 mg Linaprazan Glurate QD n = 12	50 mg Linaprazan Glurate QD n = 13	75 mg Linaprazan Glurate QD n = 12
AUC0-24h Day 1	5057 (1650.6)	8924 (2281.0)	13900 (4339.5)
AUC0-24h Day 14	4640 (1657.4)	8626 (3571.9)	11697 (4053.3)

Population analysed: Overall # of participants analyzed does not match the participant flow figures due a discrepancy between "completers" and "evaluable" participants (protocol deviations). Figures here represent the number of evaluable subjects. NB! One participant in 50mg QD discontinued before completion of the full study, but only after the primary variables had been collected. Thus this participant's data was evaluable despite being a non-completer.

Primary outcome: AUC0-12, 12-24h Linaprazan (BID)

Time frame: Day 1 and Day 14. Mean (Standard Deviation). Unit: nmol/L*h

Measure	25 mg Linaprazan Glurate BID n = 12	50 mg Linaprazan Glurate BID n = 11	75 mg Linaprazan Glurate BID n = 10
AUC0-12h Day 1	4081 (1351.9)	8084 (1400.5)	11814 (3181.8)
AUC12-24h Day 1	3947 (939.8)	7107 (1917.8)	9532 (2118.1)
AUC0-12h Day 14	4896 (1367.3)	7518 (1627.0)	11757 (3058.3)
AUC12-24h Day 14	4002 (1142.8)	6334 (2061.6)	9609 (2087.5)

Primary outcome: Cmax Linaprazan (QD)

Time frame: Day 1 and day 14. Mean (Standard Deviation). Unit: nmol/L

Measure	25 mg Linaprazan Glurate QD n = 12	50 mg Linaprazan Glurate QD n = 13	75 mg Linaprazan Glurate QD n = 12
Cmax day 1	527.5 (184.929)	1066.23 (209.973)	1594.42 (585.525)
Cmax day 14	404.75 (174.068)	1002.00 (538.574)	1044.92 (478.102)

Primary outcome: Cmax Linaprazan (BID)

Time frame: Day 1 and day 14. Mean (Standard Deviation). Unit: nmol/L

Measure	25 mg Linaprazan Glurate BID n = 12	50 mg Linaprazan Glurate BID n = 11	75 mg Linaprazan Glurate BID n = 10
Cmax 0-12h day 1	658.42 (212.101)	1380.18 (303.283)	1942.00 (667.280)
Cmax 12-24h day 1	520.92 (126.378)	997.09 (363.660)	1283.90 (435.399)
Cmax 0-12h day 14	782.92 (263.988)	1148.64 (415.251)	1740.60 (468.197)
Cmax 12-24h day 14	520.83 (144.568)	842.36 (270.396)	1285.50 (443.703)

Adverse events

Time frame: (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
25 mg Linaprazan Glurate QD	0 of 12 (0%)	6 of 12 (50%)	0 of 12
50 mg Linaprazan Glurate QD	0 of 13 (0%)	8 of 13 (61.5%)	0 of 13
75 mg Linaprazan Glurate QD	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13
25 mg Linaprazan Glurate BID	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
50 mg Linaprazan Glurate BID	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11
75 mg Linaprazan Glurate BID	1 of 12 (8.3%)	5 of 12 (41.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for GERD

RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tanja Turk, M.Pharm study director

CRS d.o.o Ljubljana, Ukmarjeva Ulica 6, Slovenia, 1000 Contact: Tanja Turk, M.pharm +38651619388 tanja.turk@crs.si

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing linaprazan glurate 25 mg QD, linaprazan glurate 50 mg QD and linaprazan glurate 75 mg QD in people with GERD, run by Cinclus Pharma Holding AB at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-24h Linaprazan (QD) (time frame: Day 1 and Day 14). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05742984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.