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CompletedNCT05742984Updated May 7, 2025Results posted

Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects

A Phase 1 interventional study of linaprazan glurate 25 mg QD and linaprazan glurate 50 mg QD in GERD, sponsored by Cinclus Pharma Holding AB. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-07.

Sponsored by Cinclus Pharma Holding AB · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 twice daily (BID), for 14 days, with an additional single dose after 2, 4 or 6 days of drug holiday. The population will include healthy male and female subjects.

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

02

Conditions studied

  • GERD
03

In context

Gastroesophageal Reflux

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's enrollment of 75 is above the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Cinclus Pharma Holding AB is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. Willing and able to give written for participation in the study.
  2. Healthy male or female subject aged 18 to 65 years, inclusive.
  3. ≥ 18.5 and ≤ 30.0 kg/m2.
  4. Medically healthy, without abnormal medical history, physical findings, vital signs, ECGs, or laboratory values at the time of screening, as judged by the Investigator.

Exclusion criteria

Exclusion Criteria:

  1. Female subjects of (defined as all subjects physiologically capable of becoming pregnant)
  2. Male subjects with a partner of childbearing potential
  3. History of any 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.
  4. History of GERD or clinically significant acid reflux, as judged by the Investigator.
Terms in these criteria, in plain language(4)

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    Group 1: 25 mg linaprazan glurate QD

    25 mg (one 25 mg oral tablet) linaprazan glurate once daily (QD) for 14 days

    Drug: linaprazan glurate 25 mg QD

  • Experimental
    Group 2: 50 mg Linaprazan Glurate QD

    50 mg (two 25 mg oral tablets) linaprazan glurate once daily (QD) for 14 days

    Drug: linaprazan glurate 50 mg QD

  • Experimental
    Group 3: 75 mg Linaprazan Glurate QD

    75 mg (three 25 mg oral tablet) linaprazan glurate once daily (QD) for 14 days

    Drug: linaprazan glurate 75 mg QD

  • Experimental
    Group 4: 25 mg Linaprazan Glurate BID

    25 mg (one 25mg oral tablet) linaprazan glurate twice daily (BID) for 14 days

    Drug: linaprazan glurate 25 mg BID

  • Experimental
    Group 5: 50 mg Linaprazan Glurate BID

    50 mg (two 25 mg oral tablets) linaprazan glurate twice daily (BID) for 14 days

    Drug: linaprazan glurate 50 mg BID

  • Experimental
    Group 6: 75 mg Linaprazan Glurate BID

    75 mg (three 25 mg oral tablet) linaprazan glurate twice daily (BID) for 14 days

    Drug: linaprazan glurate 75 mg BID

Interventions

  • Druglinaprazan glurate 25 mg QD

    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).

  • Druglinaprazan glurate 50 mg QD

    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).

  • Druglinaprazan glurate 75 mg QD

    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).

  • Druglinaprazan glurate 25 mg BID

    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).

  • Druglinaprazan glurate 50 mg BID

    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).

  • Druglinaprazan glurate 75 mg BID

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 and Day 14

  2. 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.

    Time frame: Day 1 and Day 14

  3. Cmax Linaprazan (QD)

    Linaprazan maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.

    Time frame: Day 1 and day 14

  4. Cmax Linaprazan (BID)

    Linaprazan maximum plasma concentration 0-12h, and 12-24h post dose for BID groups, at day 1 and day 14.

    Time frame: Day 1 and day 14

  5. 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.

    Time frame: Day 1 and day 14

  6. 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.

    Time frame: Day 1 and Day 14

  7. Cmax Linaprazan Glurate (QD)

    Linaprazan glurate maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.

    Time frame: Day 1 and day 14

  8. 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.

    Time frame: Day 1 and day 14

  9. 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.

    Time frame: Day 1 and day 14

07

Results

Posted May 7, 2025

Participant flow

A total of 132 subjects were screened, of which 75 subjects were randomized, including 2 subjects who did not receive any study medication. Hence 73 subjects were randomized and received at least 1 dose of linaprazan glurate. Three subjects withdrew consent and 3 subjects discontinued due to adverse AEs. A total of 69 subjects completed the study.

Participant flow — Overall Study
Milestone25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BID
Started121313121213
Completed121212121110
Not completed011013
Withdrew: Adverse event001011
Withdrew: Withdrawal by subject010002

Outcome measures

PrimaryAUC0-24h Linaprazan (QD)

Linaprazan area under the plasma concentration curve, from 0 to 24h post dose on Day 1 and Day 14. QD groups only.

Time frame:
Day 1 and Day 14
Reported as:
Mean · nmol/L*h
AUC0-24h Linaprazan (QD)
nmol/L*h25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD
AUC0-24h Day 15057 ± 1650.68924 ± 2281.013900 ± 4339.5
AUC0-24h Day 144640 ± 1657.48626 ± 3571.911697 ± 4053.3
PrimaryAUC0-12, 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.

Time frame:
Day 1 and Day 14
Reported as:
Mean · nmol/L*h
AUC0-12, 12-24h Linaprazan (BID)
nmol/L*h25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BID
AUC0-12h Day 14081 ± 1351.98084 ± 1400.511814 ± 3181.8
AUC12-24h Day 13947 ± 939.87107 ± 1917.89532 ± 2118.1
AUC0-12h Day 144896 ± 1367.37518 ± 1627.011757 ± 3058.3
AUC12-24h Day 144002 ± 1142.86334 ± 2061.69609 ± 2087.5
PrimaryCmax Linaprazan (QD)

Linaprazan maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.

Time frame:
Day 1 and day 14
Reported as:
Mean · nmol/L
Cmax Linaprazan (QD)
nmol/L25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD
Cmax day 1527.5 ± 184.9291066.23 ± 209.9731594.42 ± 585.525
Cmax day 14404.75 ± 174.0681002.00 ± 538.5741044.92 ± 478.102
PrimaryCmax Linaprazan (BID)

Linaprazan maximum plasma concentration 0-12h, and 12-24h post dose for BID groups, at day 1 and day 14.

Time frame:
Day 1 and day 14
Reported as:
Mean · nmol/L
Cmax Linaprazan (BID)
nmol/L25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BID
Cmax 0-12h day 1658.42 ± 212.1011380.18 ± 303.2831942.00 ± 667.280
Cmax 12-24h day 1520.92 ± 126.378997.09 ± 363.6601283.90 ± 435.399
Cmax 0-12h day 14782.92 ± 263.9881148.64 ± 415.2511740.60 ± 468.197
Cmax 12-24h day 14520.83 ± 144.568842.36 ± 270.3961285.50 ± 443.703
PrimaryAUC0-24h 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.

Time frame:
Day 1 and day 14
Reported as:
Mean · nmol/L*h
AUC0-24h Linaprazan Glurate (QD)
nmol/L*h25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD
AUC0-24h Day 142 ± 18.999 ± 68.0166 ± 85.5
AUC0-24h Day 1427 ± 18.6107 ± 97.9149 ± 201.1
PrimaryAUC0-12h, 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.

Time frame:
Day 1 and Day 14
Reported as:
Mean · nmol/L*h
AUC0-12h, 12-24h Linaprazan Glurate (BID)
nmol/L*h25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BID
AUC0-12h Day 140 ± 15.5117 ± 65.3179 ± 87.4
AUC 12-24h Day 130 ± 14.674 ± 40.778 ± 24.7
AUC0-12h Day 1439 ± 23.269 ± 37.0156 ± 140.6
AUC 12-24h Day 1428 ± 10.268 ± 38.1114 ± 91.2
PrimaryCmax Linaprazan Glurate (QD)

Linaprazan glurate maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.

Time frame:
Day 1 and day 14
Reported as:
Mean · nmol/L
Cmax Linaprazan Glurate (QD)
nmol/L25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD
Cmax Day 127.54 ± 21.28462.24 ± 53.653100.46 ± 64.576
Cmax Day 1418.43 ± 18.775126.31 ± 166.828107.07 ± 202.899
PrimaryCmax Linaprazan Glurate (BID)

Linaprazan glurate maximum plasma concentration 0-12h and 12-24h post dose for BID groups, at day 1 and day 14.

Time frame:
Day 1 and day 14
Reported as:
Mean · nmol/L
Cmax Linaprazan Glurate (BID)
nmol/L25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BID
Cmax0-12h Day 132.52 ± 19.704101.26 ± 49.177148.19 ± 80.799
Cmax 12-24h Day 114.69 ± 10.29046.60 ± 40.04140.41 ± 32.422
Cmax0-12h Day 1447.59 ± 46.27561.09 ± 43.234151.73 ± 145.527
Cmax 12-24h Day 1422.29 ± 13.41441.51 ± 38.11094.42 ± 140.218
PrimaryPercentage 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.

Time frame:
Day 1 and day 14
Reported as:
Mean · % of time
Percentage of Time Gastric pH >4 Over a 24-hour Monitoring Period (Holding Time Ratio, HTR)
% of time25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BID
HTR (%) pH >4 day 148 ± 23.2364.6 ± 13.3368.1 ± 23.4876.0 ± 13.5287.4 ± 8.6294.5 ± 4.18
HTR (%) pH >4 day 1448.5 ± 30.6263.9 ± 20.0987.2 ± 11.4476.9 ± 20.1395.7 ± 5.5599.0 ± 1.54

Adverse events

Collected over (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.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
25 mg Linaprazan Glurate QD0/12 (0%)0/12 (0%)6/12 (50%)
50 mg Linaprazan Glurate QD0/13 (0%)0/13 (0%)8/13 (61.5%)
75 mg Linaprazan Glurate QD0/13 (0%)0/13 (0%)6/13 (46.2%)
25 mg Linaprazan Glurate BID0/12 (0%)0/12 (0%)7/12 (58.3%)
50 mg Linaprazan Glurate BID0/11 (0%)0/11 (0%)6/11 (54.5%)
75 mg Linaprazan Glurate BID0/12 (0%)1/12 (8.3%)5/12 (41.7%)
Most frequent serious events
Most frequent serious events
Event25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BID
Commotio cerebriNervous system disorders0/120/130/130/120/111/12
Most frequent other events
Showing 10 of 31
Most frequent other events
Event25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BID
HeadacheNervous system disorders3/123/131/133/123/113/12
fatigueGeneral disorders0/121/130/130/121/111/12
CystitisInfections and infestations0/121/130/130/121/110/12
DysmenorrhoeaReproductive system and breast disorders0/121/130/130/121/110/12
Back PainMusculoskeletal and connective tissue disorders0/120/130/130/121/110/12
HaematuriaRenal and urinary disorders0/121/130/130/121/110/12
SyncopeNervous system disorders0/120/131/131/120/111/12
DizzinessNervous system disorders0/120/130/130/120/111/12
SeizureNervous system disorders0/120/130/130/120/111/12
PyrexiaGeneral disorders0/120/131/131/120/111/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BIDTotal
Mean24.1 ± 8.2624.7 ± 8.3522.8 ± 2.4522.4 ± 1.8823.9 ± 3.4825.1 ± 8.2523.8 ± 6.05
Sex: Female, Male
Sex: Female, Male(Participants)25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BIDTotal
Female56655532
Male77776741
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BIDTotal
Hispanic or Latino0000000
Not Hispanic or Latino12131312111273
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BIDTotal
American Indian or Alaska Native0000000
Asian0000000
Native Hawaiian or Other Pacific Islander0000000
Black or African American0000000
White12131312111273
More than one race0000000
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(participants)25 mg Linaprazan Glurate QD50 mg Linaprazan Glurate QD75 mg Linaprazan Glurate QD25 mg Linaprazan Glurate BID50 mg Linaprazan Glurate BID75 mg Linaprazan Glurate BIDTotal
Slovenia12131312111273
08

Study locations

1 site
  • CRS d.o.o,Ukmarjeva ulica 6
    Ljubljana, 1000, Slovenia
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05742984
Lead sponsor
Cinclus Pharma Holding AB
Responsible party
Sponsor
First posted
Feb 24, 2023
Start date
Jan 26, 2023
Primary completion
Mar 24, 2023
Completion
Apr 13, 2023
Results posted
May 7, 2025
Last update
May 7, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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