PharmacokineticsPhase 1NCT05469854
A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate
A Phase 1 study testing Linaprazan glurate in people with Pharmacokinetics and Cardiodynamic ECG, run by Cinclus Pharma Holding AB at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Cardiodynamic ECG, Safety, and Tolerability
- What is being tested?
- Linaprazan glurate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteSweden
- Study dates
- 13 Jul 2022to 30 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
Main inclusion Criteria:
- Willing and able to give written informed consent for participation in the study.
- Healthy male or female aged 18 to 65 years
- Body mass index ≥18.5 and ≤35.0 kg/m2.
- Prospective subjects, as well as their partners, must agree to contraception requirements
Main exclusion criteria:
- Female subjects of childbearing potential unless they agree to use highly effective methods of contraception (failure rate of <1%) from 2 weeks prior to dosing until the end-of-study visit.
- Male subjects with a partner of childbearing potential, unless they agree to use method of contraception from 2 weeks prior to dosing until the end-of-study visit.History of or current clinically significant disease as defined in the protocol
- History of or current clinically significant disease as defined in the protocol.
- History of GERD, significant acid reflux.
- Subjects who are pregnant, currently breastfeeding, or intend to become pregnant (female subjects) or father a child (male subjects) during the course of the study (i.e., from screening to end of study visit).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
CTC Clinical Trial Consultants AB
Uppsala, SE-75237
Kristina Ocklind, +4618303300, kristina.ocklind@ctc-ab.se
Erik Rein-Hedin, MD
About this study
Official title: A Phase I Trial to Investigate the Pharmacokinetics and ECG Effects of Single Doses of Linaprazan Glurate Administered as Oral Tablets to Healthy Participants
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).
- Conditions
- Pharmacokinetics, Cardiodynamic ECG, Safety, and Tolerability, GERD
- Being tested
- Linaprazan glurate, Placebo
- 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 glurateDrug
Also called X842
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).
PlaceboDrug
Single dose, oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Linaprazan glurate | Experimental | Oral administration as a single dose of 300 mg, 600 mg, 150 mg, 275 mg, and up to 2 additional dose levels. Receives: Drug: Linaprazan glurate |
| Placebo | Placebo comparator | Oral administration as a singel dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Up to 24 hours
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)
To assess the Maximum plasma concentration (Cmax)
Measured: Up to 24 hours
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)
To assess the Terminal elimination half-life (T1/2)
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (QTcF)
To assess the change from baseline in QTcF
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (heart rate)
To assess the change from baseline in heart rate
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (PR interval)
To assess the change from baseline in PR interval
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (QRS interval)
To assess the change from baseline in QRS interval
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected QTcF)
To assess the change from baseline in placebo-corrected QTcF
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected heart rate)
To assess the change from baseline in placebo-corrected heart rate
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected PR interval)
To assess the change from baseline in placebo-corrected PR interval
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)
To assess the change from baseline in placebo-corrected QRS interval
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (categorical outliers)
Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval)
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (changes of T-wave)
Frequency of treatment emergent changes of T-wave abnormalities
Measured: Up to 24 hours
Measurement of Cardiodynamic ECG (changes of U-wave)
Frequency of treatment emergent changes of U-wave abnormalities
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start13 Jul 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cinclus Pharma Holding AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erik Rein-Hedin, MD, Principal investigator, CTC Clinical Trial Consultants AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469854
- Sponsor's protocol ID
- CX842A2104
- Status last verified
- Jun 2026
- First submitted
- 15 Jul 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial to Investigate the Pharmacokinetics and ECG Effects of Single Doses of Linaprazan Glurate Administered as Oral Tablets to Healthy Participants
- ClinicalTrials.gov ID
- NCT05469854
- Acronym / sponsor ID
- CX842A2104
- Conditions
- Pharmacokinetics, Cardiodynamic ECG, Safety, and Tolerability, GERD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Cinclus Pharma Holding ABIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linaprazan glurate | Experimental | Drug: Linaprazan glurateOral administration as a single dose of 300 mg, 600 mg, 150 mg, 275 mg, and up to 2 additional dose levels. |
| Placebo | Placebo comparator | Drug: PlaceboOral administration as a singel dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 glurateAlso: X842Linaprazan 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). | Drug | Linaprazan glurate |
| PlaceboSingle dose, oral tablets | Drug | Placebo |
Primary outcome
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)
Time frame: Up to 24 hours
To assess the Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (AUCinf)
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)
Time frame: Up to 24 hours
To assess the AUC from time 0 to the last measurable concentration (AUClast)
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)
Time frame: Up to 24 hours
To assess the Maximum plasma concentration (Cmax)
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)
Time frame: Up to 24 hours
To assess the Terminal elimination half-life (T1/2)
Measurement of Cardiodynamic ECG (QTcF)
Time frame: Up to 24 hours
To assess the change from baseline in QTcF
Measurement of Cardiodynamic ECG (heart rate)
Time frame: Up to 24 hours
To assess the change from baseline in heart rate
Measurement of Cardiodynamic ECG (PR interval)
Time frame: Up to 24 hours
To assess the change from baseline in PR interval
Measurement of Cardiodynamic ECG (QRS interval)
Time frame: Up to 24 hours
To assess the change from baseline in QRS interval
Measurement of Cardiodynamic ECG (placebo-corrected QTcF)
Time frame: Up to 24 hours
To assess the change from baseline in placebo-corrected QTcF
Measurement of Cardiodynamic ECG (placebo-corrected heart rate)
Time frame: Up to 24 hours
To assess the change from baseline in placebo-corrected heart rate
Measurement of Cardiodynamic ECG (placebo-corrected PR interval)
Time frame: Up to 24 hours
To assess the change from baseline in placebo-corrected PR interval
Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)
Time frame: Up to 24 hours
To assess the change from baseline in placebo-corrected QRS interval
Measurement of Cardiodynamic ECG (categorical outliers)
Time frame: Up to 24 hours
Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval)
Measurement of Cardiodynamic ECG (changes of T-wave)
Time frame: Up to 24 hours
Frequency of treatment emergent changes of T-wave abnormalities
Measurement of Cardiodynamic ECG (changes of U-wave)
Time frame: Up to 24 hours
Frequency of treatment emergent changes of U-wave abnormalities
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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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.
Erik Rein-Hedin, MD principal investigator
CTC Clinical Trial Consultants AB
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 in people with Pharmacokinetics and Cardiodynamic ECG, run by Cinclus Pharma Holding AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Leyman, MD (+32 470214020, sophie.leyman@cincluspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf) (time frame: Up to 24 hours). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.