Drug InteractionPhase 1NCT07308041
A Study to Investigate the Effect of Linaprazan Glurate on the Pharmacokinetics of Amoxicillin
A Phase 1 study testing Drug Drug Interaction in people with Drug Interaction and GERD (Gastroesophageal Reflux Disease), run by Cinclus Pharma Holding AB at 1 site in Sweden.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction, GERD (Gastroesophageal Reflux Disease), Safety, and Tolerability
- What is being tested?
- Drug Drug Interaction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 11 Nov 2025to 22 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give written informed consent for participation in the trial.
- Healthy male or female participant aged 18 to 64 years, inclusive.
- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.
- Prospective participants, as well as their partners, must agree to the contraception requirements described in exclusion criteria 1 and 2.
Who cannot join
- Female participants of childbearing potential (defined as all participants physiologically capable of becoming pregnant) unless they agree to use one of the following highly effective methods of contraception (failure rate of <1%) from 2 weeks prior to the first dose until the end-of-trial visit:
- Sterilization of a male partner, defined as vasectomy, at least six months prior to screening.
- Intra-uterine device (non-hormonal or copper IUD).
- Double-barrier methods of contraception, i.e., condoms in combination with occlusive cap with contraceptive gel.
- 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:
- Vasectomy at least six months prior to screening.
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- Condoms. Female partners of childbearing potential must then agree to concurrently use a highly effective method of contraception.
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- Any clinically significant illness, medical/surgical procedure or trauma within four weeks of the first administration of IMP.
- Positive result for H.pylori antibodies at the time of the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Single Arm, Single-center, Phase 1 Trial Investigating the Effect of 7-days-repeated Administration of Linaprazan Glurate on the Pharmacokinetics of Repeated Doses of Amoxicillin in Healthy Participants
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
Read the detailed description
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.
- Being tested
- Drug Drug Interaction
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Drug InteractionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Linaprazan glurate | Experimental | Oral administration for seven (7) days. Receives: Drug: Drug Drug Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start11 Nov 2025
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinclus Pharma Holding AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308041
- Sponsor's protocol ID
- CX842B2111
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single Arm, Single-center, Phase 1 Trial Investigating the Effect of 7-days-repeated Administration of Linaprazan Glurate on the Pharmacokinetics of Repeated Doses of Amoxicillin in Healthy Participants
- ClinicalTrials.gov ID
- NCT07308041
- Acronym / sponsor ID
- CX842B2111
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cinclus Pharma Holding ABIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 29 Dec 2025 (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 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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linaprazan glurate | Experimental | Drug: Drug Drug InteractionOral administration for seven (7) days. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to give written informed consent for participation in the trial.
- Healthy male or female participant aged 18 to 64 years, inclusive.
- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.
- Prospective participants, as well as their partners, must agree to the contraception requirements described in exclusion criteria 1 and 2.
Key exclusion criteria (10 listed)
- Female participants of childbearing potential (defined as all participants physiologically capable of becoming pregnant) unless they agree to use one of the following highly effective methods of contraception (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:
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- Any clinically significant illness, medical/surgical procedure or trauma within four weeks of the first administration of IMP.
- Positive result for H.pylori antibodies at the time of the screening visit.
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 |
|---|---|---|
| Drug Drug InteractionThe 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. | Drug | Linaprazan glurate |
Primary outcome
Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (AUC)
Time frame: Day 1 and Day 8
Geometric mean ratio Day 8/Day 1 for amoxicillin Area Under the Plasma Concentration vs. Time Curve (AUC)
Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (Cmax)
Time frame: Day 1 and Day 8
Geometric mean ratio Day 8/Day 1 for amoxicillin Cmax
Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (Tmax)
Time frame: Day 1 and Day 8
Amoxicillin Tmax
Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (CL/F)
Time frame: Day 1 and Day 8
Amoxicillin apparent oral clearance (CL/F)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Drug Drug Interaction in people with Drug Interaction and GERD (Gastroesophageal Reflux Disease), 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?
The sponsor lists 5 inclusion and 10 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 27 Feb 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (AUC) (time frame: Day 1 and Day 8). The study lists 4 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 27 Feb 2026.