Clinical trial NCT05469854: A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate
Official title: A Phase I Study to Investigate the Pharmacokinetics and ECG Effects of Two Single Ascending Doses of Linaprazan Glurate Given as Oral Tablets to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pharmacokinetics
Cardiodynamic ECG
Safety, and Tolerability
GERD
Lead sponsor: Cinclus Pharma AG
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Main inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.
2. Healthy male or female aged 18 to 65 years
3. Body mass index ≥18.5 and ≤35.0 kg/m2.
4. Prospective subjects, as well as their partners, must agree to contraception requirements

Main exclusion criteria:

1. 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.
2. 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
3. History of or current clinically significant disease as defined in the protocol.
4. History of GERD, significant acid reflux.
5. 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).

Primary outcomes:
measure: Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)
timeFrame: Up to 24 hours
measure: Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)
timeFrame: Up to 24 hours
measure: Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)
timeFrame: Up to 24 hours
measure: Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (QTcF)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (heart rate)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (PR interval)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (QRS interval)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (placebo-corrected QTcF)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (placebo-corrected heart rate)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (placebo-corrected PR interval)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (categorical outliers)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (changes of T-wave)
timeFrame: Up to 24 hours
measure: Measurement of Cardiodynamic ECG (changes of U-wave)
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: CTC Clinical Trial Consultants AB
Study officials:
affiliation: CTC Clinical Trial Consultants AB
name: Erik Rein-Hedin, MD
role: PRINCIPAL_INVESTIGATOR
References: