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

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.

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