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
Overview
- Phase
- Phase 1
- Intervention
- Linaprazan glurate
- Conditions
- Pharmacokinetics
- Sponsor
- Cinclus Pharma AG
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Linaprazan glurate
Oral administration as a single dose of 300 mg, 600 mg, 200 mg, and a final dose level of maximum 400 mg.
Intervention: Linaprazan glurate
Placebo
Oral administration as a singel dose
Intervention: Placebo
Outcomes
Primary Outcomes
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)
Time Frame: Up to 24 hours
To assess the AUC from time 0 to the last measurable concentration (AUClast)
Measurement of Cardiodynamic ECG (QTcF)
Time Frame: Up to 24 hours
To assess the change from baseline in QTcF
Measurement of Cardiodynamic ECG (PR interval)
Time Frame: Up to 24 hours
To assess the change from baseline in PR interval
Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)
Time Frame: Up to 24 hours
To assess the change from baseline in placebo-corrected QRS interval
Measurement of Cardiodynamic ECG (changes of T-wave)
Time Frame: Up to 24 hours
Frequency of treatment emergent changes of T-wave abnormalities
Measurement of Cardiodynamic ECG (placebo-corrected PR interval)
Time Frame: Up to 24 hours
To assess the change from baseline in placebo-corrected PR interval
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)
Time Frame: Up to 24 hours
To assess the Maximum plasma concentration (Cmax)
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)
Time Frame: Up to 24 hours
To assess the Terminal elimination half-life (T1/2)
Measurement of Cardiodynamic ECG (placebo-corrected QTcF)
Time Frame: Up to 24 hours
To assess the change from baseline in placebo-corrected QTcF
Measurement of Cardiodynamic ECG (placebo-corrected heart rate)
Time Frame: Up to 24 hours
To assess the change from baseline in placebo-corrected heart rate
Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)
Time Frame: Up to 24 hours
To assess the Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (AUCinf)
Measurement of Cardiodynamic ECG (heart rate)
Time Frame: Up to 24 hours
To assess the change from baseline in heart rate
Measurement of Cardiodynamic ECG (QRS interval)
Time Frame: Up to 24 hours
To assess the change from baseline in QRS interval
Measurement of Cardiodynamic ECG (categorical outliers)
Time Frame: Up to 24 hours
Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval)
Measurement of Cardiodynamic ECG (changes of U-wave)
Time Frame: Up to 24 hours
Frequency of treatment emergent changes of U-wave abnormalities