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A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate
Sponsor: Cinclus Pharma Holding AB
Summary
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).
Official title: A Phase I Trial to Investigate the Pharmacokinetics and ECG Effects of Single Doses of Linaprazan Glurate Administered as Oral Tablets to Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
121
Start Date
2022-07-13
Completion Date
2026-11-30
Last Updated
2026-06-17
Healthy Volunteers
Yes
Interventions
Linaprazan glurate
Linaprazan glurate base formulation, 25 mg oral tablets (300 mg and 600 mg doses). Linaprazan glurate hydrochloride (HCl), 25 mg and 50 mg (as base) oral tablets (150 mg, 275 mg and up to 2 additional dose levels).
Placebo
Single dose, oral tablets
Locations (1)
CTC Clinical Trial Consultants AB
Uppsala, Sweden