A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate

Launched by CINCLUS PHARMA AG · Jul 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called linaprazan glurate, which is being tested to understand how it works in the body, its effects on heart activity, and its safety. Participants will receive different single doses of this medication to see how it affects them and to ensure it is tolerable. The trial is taking place at a single location and is designed to be double-blind, meaning neither the participants nor the researchers will know who receives the actual medication or a placebo (a non-active pill) during the study.

To be eligible for this trial, participants should be healthy adults aged 18 to 65 years, with a body weight within a specific range. They must be willing to follow certain guidelines regarding contraception during the study. If you join, you’ll be monitored for any side effects and how well your body absorbs the medication. This trial is currently recruiting, so if you're interested or have questions, it's a good idea to talk to your healthcare provider for more information.

Gender

ALL

Eligibility 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).