A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate
- 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).
- Short title
- A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-11-30
- First posted
- 2022-07-22
- Registry last updated
- 2026-06-17
- Primary completion date
- 2026-11-30
- Start date
- 2022-07-13
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Cinclus Pharma Holding AB
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05469854
- ClinicalTrials.gov ID
- NCT05469854
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)
Timeframe: Up to 24 hours
To assess the Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (AUCinf)
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)
Timeframe: Up to 24 hours
To assess the AUC from time 0 to the last measurable concentration (AUClast)
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)
Timeframe: Up to 24 hours
To assess the Maximum plasma concentration (Cmax)
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)
Timeframe: Up to 24 hours
To assess the Terminal elimination half-life (T1/2)
Measurement of Cardiodynamic ECG (QTcF)
Timeframe: Up to 24 hours
To assess the change from baseline in QTcF
Measurement of Cardiodynamic ECG (heart rate)
Timeframe: Up to 24 hours
To assess the change from baseline in heart rate
Measurement of Cardiodynamic ECG (PR interval)
Timeframe: Up to 24 hours
To assess the change from baseline in PR interval
Measurement of Cardiodynamic ECG (QRS interval)
Timeframe: Up to 24 hours
To assess the change from baseline in QRS interval
Measurement of Cardiodynamic ECG (placebo-corrected QTcF)
Timeframe: Up to 24 hours
To assess the change from baseline in placebo-corrected QTcF
Measurement of Cardiodynamic ECG (placebo-corrected heart rate)
Timeframe: Up to 24 hours
To assess the change from baseline in placebo-corrected heart rate
Measurement of Cardiodynamic ECG (placebo-corrected PR interval)
Timeframe: Up to 24 hours
To assess the change from baseline in placebo-corrected PR interval
Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)
Timeframe: Up to 24 hours
To assess the change from baseline in placebo-corrected QRS interval
Measurement of Cardiodynamic ECG (categorical outliers)
Timeframe: Up to 24 hours
Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval)
Measurement of Cardiodynamic ECG (changes of T-wave)
Timeframe: Up to 24 hours
Frequency of treatment emergent changes of T-wave abnormalities
Measurement of Cardiodynamic ECG (changes of U-wave)
Timeframe: Up to 24 hours
Frequency of treatment emergent changes of U-wave abnormalities
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
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).
- CTC Clinical Trial Consultants ABUppsala, SwedenRecruiting