NCT05742984 is a Phase 1 clinical trial of linaprazan glurate 25 mg QD in GERD, sponsored by Cinclus Pharma Holding AB.

Who is sponsoring NCT05742984?

NCT05742984 is sponsored by Cinclus Pharma Holding AB.

What drugs are being tested in NCT05742984?

Interventions in NCT05742984: 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, linaprazan glurate 75 mg BID.

Is NCT05742984 still recruiting?

NCT05742984 is currently completed. Last updated 7 May 2025.

Are results published for NCT05742984?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-07 · How we verify

NCT05742984

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects

Completed Phase 1 Results posted Last updated 7 May 2025

What this trial tests

Phase 1 trial testing linaprazan glurate 25 mg QD in GERD in 75 participants. Completed in 13 April 2023.

Timeline

26 January 2023

Primary endpoint
24 March 2023

13 April 2023

Quick facts

Lead sponsor	Cinclus Pharma Holding AB
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	26 January 2023
Primary completion	24 March 2023
Estimated completion	13 April 2023
Sites	1 location across Slovenia

Drugs / interventions tested

linaprazan glurate 25 mg QD — full drug profile →
linaprazan glurate 50 mg QD — full drug profile →
linaprazan glurate 75 mg QD — full drug profile →
linaprazan glurate 25 mg BID
linaprazan glurate 50 mg BID — full drug profile →
linaprazan glurate 75 mg BID — full drug profile →

Conditions studied

GERD — all drugs for GERD →

Sponsor

Cinclus Pharma Holding AB — full company profile →

Who can join

Adults 18 to 65, any sex, with GERD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

AUC0-24h Linaprazan (QD) Primary · 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.

AUC0-24h Day 1

Group	Value	95% CI
25 mg Linaprazan Glurate QD	5057	± 1650.6
50 mg Linaprazan Glurate QD	8924	± 2281.0
75 mg Linaprazan Glurate QD	13900	± 4339.5

AUC0-24h Day 14

Group	Value	95% CI
25 mg Linaprazan Glurate QD	4640	± 1657.4
50 mg Linaprazan Glurate QD	8626	± 3571.9
75 mg Linaprazan Glurate QD	11697	± 4053.3

AUC0-12, 12-24h Linaprazan (BID) Primary · 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.

AUC0-12h Day 1

Group	Value	95% CI
25 mg Linaprazan Glurate BID	4081	± 1351.9
50 mg Linaprazan Glurate BID	8084	± 1400.5
75 mg Linaprazan Glurate BID	11814	± 3181.8

AUC12-24h Day 1

Group	Value	95% CI
25 mg Linaprazan Glurate BID	3947	± 939.8
50 mg Linaprazan Glurate BID	7107	± 1917.8
75 mg Linaprazan Glurate BID	9532	± 2118.1

AUC0-12h Day 14

Group	Value	95% CI
25 mg Linaprazan Glurate BID	4896	± 1367.3
50 mg Linaprazan Glurate BID	7518	± 1627.0
75 mg Linaprazan Glurate BID	11757	± 3058.3

AUC12-24h Day 14

Group	Value	95% CI
25 mg Linaprazan Glurate BID	4002	± 1142.8
50 mg Linaprazan Glurate BID	6334	± 2061.6
75 mg Linaprazan Glurate BID	9609	± 2087.5

Cmax Linaprazan (QD) Primary · Day 1 and day 14

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

Cmax day 1

Group	Value	95% CI
25 mg Linaprazan Glurate QD	527.5	± 184.929
50 mg Linaprazan Glurate QD	1066.23	± 209.973
75 mg Linaprazan Glurate QD	1594.42	± 585.525

Cmax day 14

Group	Value	95% CI
25 mg Linaprazan Glurate QD	404.75	± 174.068
50 mg Linaprazan Glurate QD	1002.00	± 538.574
75 mg Linaprazan Glurate QD	1044.92	± 478.102

Cmax Linaprazan (BID) Primary · 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.

Cmax 0-12h day 1

Group	Value	95% CI
25 mg Linaprazan Glurate BID	658.42	± 212.101
50 mg Linaprazan Glurate BID	1380.18	± 303.283
75 mg Linaprazan Glurate BID	1942.00	± 667.280

Cmax 12-24h day 1

Group	Value	95% CI
25 mg Linaprazan Glurate BID	520.92	± 126.378
50 mg Linaprazan Glurate BID	997.09	± 363.660
75 mg Linaprazan Glurate BID	1283.90	± 435.399

Cmax 0-12h day 14

Group	Value	95% CI
25 mg Linaprazan Glurate BID	782.92	± 263.988
50 mg Linaprazan Glurate BID	1148.64	± 415.251
75 mg Linaprazan Glurate BID	1740.60	± 468.197

Cmax 12-24h day 14

Group	Value	95% CI
25 mg Linaprazan Glurate BID	520.83	± 144.568
50 mg Linaprazan Glurate BID	842.36	± 270.396
75 mg Linaprazan Glurate BID	1285.50	± 443.703

AUC0-24h Linaprazan Glurate (QD) Primary · 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.

AUC0-24h Day 1

Group	Value	95% CI
25 mg Linaprazan Glurate QD	42	± 18.9
50 mg Linaprazan Glurate QD	99	± 68.0
75 mg Linaprazan Glurate QD	166	± 85.5

AUC0-24h Day 14

Group	Value	95% CI
25 mg Linaprazan Glurate QD	27	± 18.6
50 mg Linaprazan Glurate QD	107	± 97.9
75 mg Linaprazan Glurate QD	149	± 201.1

AUC0-12h, 12-24h Linaprazan Glurate (BID) Primary · 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.

AUC0-12h Day 1

Group	Value	95% CI
25 mg Linaprazan Glurate BID	40	± 15.5
50 mg Linaprazan Glurate BID	117	± 65.3
75 mg Linaprazan Glurate BID	179	± 87.4

AUC 12-24h Day 1

Group	Value	95% CI
25 mg Linaprazan Glurate BID	30	± 14.6
50 mg Linaprazan Glurate BID	74	± 40.7
75 mg Linaprazan Glurate BID	78	± 24.7

AUC0-12h Day 14

Group	Value	95% CI
25 mg Linaprazan Glurate BID	39	± 23.2
50 mg Linaprazan Glurate BID	69	± 37.0
75 mg Linaprazan Glurate BID	156	± 140.6

AUC 12-24h Day 14

Group	Value	95% CI
25 mg Linaprazan Glurate BID	28	± 10.2
50 mg Linaprazan Glurate BID	68	± 38.1
75 mg Linaprazan Glurate BID	114	± 91.2

Cmax Linaprazan Glurate (QD) Primary · Day 1 and day 14

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

Cmax Day 1

Group	Value	95% CI
25 mg Linaprazan Glurate QD	27.54	± 21.284
50 mg Linaprazan Glurate QD	62.24	± 53.653
75 mg Linaprazan Glurate QD	100.46	± 64.576

Cmax Day 14

Group	Value	95% CI
25 mg Linaprazan Glurate QD	18.43	± 18.775
50 mg Linaprazan Glurate QD	126.31	± 166.828
75 mg Linaprazan Glurate QD	107.07	± 202.899

Cmax Linaprazan Glurate (BID) Primary · 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.

Cmax0-12h Day 1

Group	Value	95% CI
25 mg Linaprazan Glurate BID	32.52	± 19.704
50 mg Linaprazan Glurate BID	101.26	± 49.177
75 mg Linaprazan Glurate BID	148.19	± 80.799

Cmax 12-24h Day 1

Group	Value	95% CI
25 mg Linaprazan Glurate BID	14.69	± 10.290
50 mg Linaprazan Glurate BID	46.60	± 40.041
75 mg Linaprazan Glurate BID	40.41	± 32.422

Cmax0-12h Day 14

Group	Value	95% CI
25 mg Linaprazan Glurate BID	47.59	± 46.275
50 mg Linaprazan Glurate BID	61.09	± 43.234
75 mg Linaprazan Glurate BID	151.73	± 145.527

Cmax 12-24h Day 14

Group	Value	95% CI
25 mg Linaprazan Glurate BID	22.29	± 13.414
50 mg Linaprazan Glurate BID	41.51	± 38.110
75 mg Linaprazan Glurate BID	94.42	± 140.218

Percentage of Time Gastric pH >4 Over a 24-hour Monitoring Period (Holding Time Ratio, HTR) Primary · 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.

HTR (%) pH >4 day 1

Group	Value	95% CI
25 mg Linaprazan Glurate QD	48	± 23.23
50 mg Linaprazan Glurate QD	64.6	± 13.33
75 mg Linaprazan Glurate QD	68.1	± 23.48
25 mg Linaprazan Glurate BID	76.0	± 13.52
50 mg Linaprazan Glurate BID	87.4	± 8.62
75 mg Linaprazan Glurate BID	94.5	± 4.18

HTR (%) pH >4 day 14

Group	Value	95% CI
25 mg Linaprazan Glurate QD	48.5	± 30.62
50 mg Linaprazan Glurate QD	63.9	± 20.09
75 mg Linaprazan Glurate QD	87.2	± 11.44
25 mg Linaprazan Glurate BID	76.9	± 20.13
50 mg Linaprazan Glurate BID	95.7	± 5.55
75 mg Linaprazan Glurate BID	99.0	± 1.54

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

25 mg Linaprazan Glurate QD

Serious: 0/12 (0%)

Deaths: 0/12

50 mg Linaprazan Glurate QD

Serious: 0/13 (0%)

Deaths: 0/13

75 mg Linaprazan Glurate QD

Serious: 0/13 (0%)

Deaths: 0/13

25 mg Linaprazan Glurate BID

Serious: 0/12 (0%)

Deaths: 0/12

50 mg Linaprazan Glurate BID

Serious: 0/11 (0%)

Deaths: 0/11

75 mg Linaprazan Glurate BID

Serious: 1/12 (8%)

Deaths: 0/12

Serious adverse events (1 terms)

Reaction	System	25 mg Linaprazan Glurate QD	50 mg Linaprazan Glurate QD	75 mg Linaprazan Glurate QD	25 mg Linaprazan Glurate BID	50 mg Linaprazan Glurate BID	75 mg Linaprazan Glurate BID
Commotio cerebri	Nervous system disorders	—	—	—	—	—	—

Other adverse events (31 terms — click to expand)

Reaction	System	25 mg Linaprazan Glurate QD	50 mg Linaprazan Glurate QD	75 mg Linaprazan Glurate QD	25 mg Linaprazan Glurate BID	50 mg Linaprazan Glurate BID	75 mg Linaprazan Glurate BID
Headache	Nervous system disorders	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—	—	—
fatigue	General disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—
nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Gastrointestinal infection	Infections and infestations	—	—	—	—	—	—
Herpes Simplex	Infections and infestations	—	—	—	—	—	—
Urinary Tract infections	Infections and infestations	—	—	—	—	—	—
Dysmenorrhoea	Reproductive system and breast disorders	—	—	—	—	—	—
menstrual disorder	Reproductive system and breast disorders	—	—	—	—	—	—
oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Sinonasal obstruction	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—
Leukocyturia	Renal and urinary disorders	—	—	—	—	—	—
Post streptoccocal glumerulonephritis	Renal and urinary disorders	—	—	—	—	—	—
proteinuria	Renal and urinary disorders	—	—	—	—	—	—
concussion	Injury, poisoning and procedural complications	—	—	—	—	—	—
Facial Bones fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
arterial puncture	Surgical and medical procedures	—	—	—	—	—	—
Phlebitis	Vascular disorders	—	—	—	—	—	—

Most-reported serious reactions: Commotio cerebri.

Data from ClinicalTrials.gov NCT05742984 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for GERD

Currently open trials in the same condition.

NCT06953986 — A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA · NA · recruiting
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NCT06955520 — Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM · NA · recruiting
NCT06641375 — Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients: · NA · recruiting

Other Cinclus Pharma Holding AB trials

Trials by the same sponsor.

NCT07308041 — A Study to Investigate the Effect of Linaprazan Glurate on the Pharmacokinetics of Amoxicillin · Phase 1 · completed
NCT05633147 — Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam · Phase 1 · completed
NCT05627518 — Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05742984 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cinclus Pharma Holding AB
Last refreshed: 7 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05742984.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05742984

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for GERD

Other Cinclus Pharma Holding AB trials

Verify against primary sources