Investigating the effects of linaprazan glurate on the body and heart
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
Run by Cinclus Pharma Holding AB · NCT05469854 · Data updated 2026-11-12
This study is testing a new medication called linaprazan glurate to see how it affects the body and heart in healthy people.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 121 (estimated) |
| Sponsor | Cinclus Pharma Holding AB Industry-sponsored |
| Locations | 1 site (Uppsala) |
| Status | Recruiting |
| Started | July 13, 2022 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT05469854 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy males and females aged 18 to 65 with a BMI between 18.5 and 35.0.
✕Probably not a fit
Patients with a history of GERD or significant acid reflux may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase I clinical trial is designed to evaluate the pharmacokinetics and cardiodynamic ECG effects of linaprazan glurate, a new medication. It is a single-center, double-blind, placebo-controlled study that will administer various single ascending oral doses of the drug to healthy participants. The study aims to assess the safety and tolerability of linaprazan glurate while monitoring its effects on heart function through ECG measurements. Participants will receive either the active drug or a placebo in a randomized manner.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and efficacy of linaprazan glurate for treating conditions like GERD.
How similar studies have gone: Other studies investigating pharmacokinetics and ECG effects of similar medications have shown promising results, suggesting this approach is viable.
Who can join: the full rules
Show full inclusion / exclusion criteria
Main inclusion Criteria: 1. Willing and able to give written informed consent for participation in the study. 2. Healthy male or female aged 18 to 65 years 3. Body mass index ≥18.5 and ≤35.0 kg/m2. 4. Prospective subjects, as well as their partners, must agree to contraception requirements Main exclusion criteria: 1. 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. 2. 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 3. History of or current clinically significant disease as defined in the protocol. 4. History of GERD, significant acid reflux. 5. 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).
Where it's running
-
CTC Clinical Trial Consultants AB
Uppsala, Sweden Recruiting
Study contacts
- Principal investigator: Erik Rein-Hedin, MD — CTC Clinical Trial Consultants AB
- Study coordinator: Sophie Leyman, MD
- Email: sophie.leyman@cincluspharma.com
- Phone: +32 470214020
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.