What is linaprazan glurate studying for GERD?

Linaprazan glurate is being studied to understand its pharmacokinetics and effects on heart electrical activity in healthy adults. This trial evaluates how the drug moves through the body, its impact on ECG measurements, and its safety and tolerability. The study is sponsored by Cinclus Pharma Holding AB.

Who may be eligible for this GERD clinical trial?

Adults aged 18 to 65 years who are healthy and able to provide informed consent may be eligible. Participants must have a body mass index between 18.5 and 35.0 kg/m2 and agree to contraception requirements if applicable. People with a history of GERD or significant acid reflux are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this GERD clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 65Years

All Genders

Healthy Volunteers

ID05469854

Phase I Study of Single Oral Doses of Linaprazan Glurate Tablets to Assess Pharmacokinetics and Heart Electrical Effects in Healthy Adults

Led by Cinclus Pharma Holding AB · Updated on 2026-06-17

121

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This trial evaluates the pharmacokinetics, cardiodynamic ECG effects, safety, and tolerability of single oral doses of linaprazan glurate in healthy adults aged 18 to 65 years. It is a Phase I, randomized, double-blind, placebo-controlled study designed to understand how the drug behaves in the body, its effects on heart electrical activity, and overall safety after dosing. Participants receive single oral doses of linaprazan glurate at varying levels 300 mg and 600 mg using formulation A, and 150 mg, 275 mg, and up to two additional dose levels using formulation C. A placebo group is included for comparison. The study uses a parallel-group design with quadruple masking to ensure unbiased results. During the study, participants undergo pharmacokinetic blood sampling and continuous ECG monitoring for up to 24 hours post-dose to measure drug levels and heart electrical activity changes. Researchers assess multiple ECG parameters, including QTcF, heart rate, PR and QRS intervals, and look for any abnormalities. Safety and tolerability are also monitored throughout. Total participation time per dose is about 24 hours.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Willing and able to give written informed consent for participation in the study.
Healthy male or female aged 18 to 65 years.
Body mass index between 18.5 and 35.0 kg/m2.
Prospective subjects and their partners must agree to contraception requirements.

You will not qualify if you...

Female subjects of childbearing potential not agreeing to use highly effective contraception from 2 weeks prior to dosing until study end.
Male subjects with partners of childbearing potential not agreeing to contraception from 2 weeks prior to dosing until study end.
History of or current clinically significant disease as defined in the protocol.
History of gastroesophageal reflux disease (GERD) or significant acid reflux.
Pregnant, currently breastfeeding, or intending to become pregnant or father a child during the study.

Research Team

Sophie Leyman, MD

Kajsa Larsson, MD, PhD

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