Investigating the effects of linaprazan glurate on the body and heart
A Phase I Study to Investigate the Pharmacokinetics and ECG Effects of Two Single Ascending Doses of Linaprazan Glurate Given as Oral Tablets to Healthy Subjects
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 |
| Enrollment | 113 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cinclus Pharma AG Industry-sponsored |
| Locations | 1 site (Uppsala) |
| Trial ID | NCT05469854 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 65 with a BMI between 18.5 and 35.0.
Not a fit: Patients with a history of GERD or significant acid reflux may not benefit from this study.
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 performed: Other studies investigating pharmacokinetics and ECG effects of similar medications have shown promising results, suggesting this approach is viable.
Eligibility criteria
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 this trial is running
Uppsala
- CTC Clinical Trial Consultants AB — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Erik Rein-Hedin, MD — CTC Clinical Trial Consultants AB
- Study coordinator: Simon Rubinstein, MD, PhD
- Email: simon.rubinstein@cincluspharma.com
- Phone: +44 786 780 70 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.