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

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Description

This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized study designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of 2 single ascending oral doses of linaprazan glurate. The study 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, 600 mg, 200 mg and a final dose level of maximum 400 mg) of linaprazan glurate, using 25 mg base formulation (300 mg and 600 mg doses) and 25 mg and 100 mg HCl formulation (200 mg and final dose level of maximum 400 mg) oral tablets.

Study Overview

Start Date
July 13, 2022
Completion Date
December 2, 2024
Enrollment
113
Date Posted
July 22, 2022
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
CTC Clinical Trial Consultants AB
Uppsala SE-75237, Sweden

Eligibility

Minimum Age (years)
18
Maximum Age (years)
65
Eligibility Criteria
Main inclusion Criteria:

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 ≥18.5 and ≤35.0 kg/m2.
Prospective subjects, as well as their partners, must agree to contraception requirements

Main exclusion criteria:

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.
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
History of or current clinically significant disease as defined in the protocol.
History of GERD, significant acid reflux.
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).

Study Contact Info

Study Contact Name
Simon Rubinstein, MD, PhD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05469854