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New treatment option for Pharmacokinetics
Official title A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate
ClinicalTrials.gov ID: NCT05469854
What this study is testing
What is Linaprazan glurate?
Linaprazan glurate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pharmacokinetics.
Also referred to as X842.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Main
- 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 people, as well as their partners, must agree to contraception requirements Main
You likely can't join if
- Female people of childbearing potential unless they agree to use highly effective methods of contraception (failure rate of \<1%) from 2 weeks prior...
- Male people with a partner of childbearing potential, unless they agree to use method of contraception from 2 weeks prior to dosing until the...
- History of or current clinically significant disease as defined in the protocol.
- History of GERD, significant acid reflux.
- people who are pregnant, currently breastfeeding, or intend to become pregnant (female people) or father a child (male people) during the course of...
The study team makes the final eligibility decision.
Where it's taking place
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.