Condition: Pharmacokinetics · Cardiodynamic ECG · Safety, and Tolerability · Sponsor: Cinclus Pharma Holding AB
This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized trial designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of single oral doses of linaprazan glurate. The trial will explore the PK properties of linaprazan glurate and linaprazan as well as the cardiodynamic ECG effects, safety, and tolerability after the administration of single doses: 300 mg and 600 mg in Part I of the trial, using formulation A of linaprazan glurate, as well as 150 mg, 275 mg, and up to 2 additional dose levels, using formulation C of linaprazan glurate to reach target linaprazan mean Cmax exposure (5222 nmol/L).
This description comes directly from the study's public registry record.
Sophie Leyman, MD · +32 470214020 · sophie.leyman@cincluspharma.com
Kajsa Larsson, MD, PhD · +46 70 675 01 28 · kajsa.larsson@cincluspharma.com
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Source record: clinicaltrials.gov/study/NCT05469854