12 healthy volunteers test drug combo in Early-Stage study
NCT ID NCT07308041
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study looked at how a new GERD drug, linaprazan glurate, changes the way the body processes the antibiotic amoxicillin. Twelve healthy adults took amoxicillin alone and then again after a week of the GERD drug. The goal was to measure drug levels in the blood, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
12 people
The number who actually took part.
- Started
-
Nov 2025
- Finished
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Dec 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 64 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CTC Clinical Trial Consultants AB
Uppsala, 752 37, Sweden
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Other studies related to the condition(s) this trial covers.
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