A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate
Study Details
Study Description
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 300 mg and 600 mg doses of linaprazan glurate.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Linaprazan glurate Oral administration as a single dose of 300 mg or 600 mg |
Drug: Linaprazan glurate
Oral tablet containing 25mg linaprazan glurate, an inhibitor of gastric H+, K+-ATPase by K+-competitive binding.
Other Names:
|
Placebo Comparator: Placebo Oral administration as a singel dose |
Drug: Linaprazan glurate
Oral tablet containing 25mg linaprazan glurate, an inhibitor of gastric H+, K+-ATPase by K+-competitive binding.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf) [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) [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) [Up to 24 hours]
To assess the Maximum plasma concentration (Cmax)
- Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2) [Up to 24 hours]
To assess the Terminal elimination half-life (T1/2)
- Measurement of Cardiodynamic ECG (QTcF) [Up to 24 hours]
To assess the change from baseline in QTcF
- Measurement of Cardiodynamic ECG (heart rate) [Up to 24 hours]
To assess the change from baseline in heart rate
- Measurement of Cardiodynamic ECG (PR interval) [Up to 24 hours]
To assess the change from baseline in PR interval
- Measurement of Cardiodynamic ECG (QRS interval) [Up to 24 hours]
To assess the change from baseline in QRS interval
- Measurement of Cardiodynamic ECG (placebo-corrected QTcF) [Up to 24 hours]
To assess the change from baseline in placebo-corrected QTcF
- Measurement of Cardiodynamic ECG (placebo-corrected heart rate) [Up to 24 hours]
To assess the change from baseline in placebo-corrected heart rate
- Measurement of Cardiodynamic ECG (placebo-corrected PR interval) [Up to 24 hours]
To assess the change from baseline in placebo-corrected PR interval
- Measurement of Cardiodynamic ECG (placebo-corrected QRS interval) [Up to 24 hours]
To assess the change from baseline in placebo-corrected QRS interval
- Measurement of Cardiodynamic ECG (categorical outliers) [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) [Up to 24 hours]
Frequency of treatment emergent changes of T-wave abnormalities
- Measurement of Cardiodynamic ECG (changes of U-wave) [Up to 24 hours]
Frequency of treatment emergent changes of U-wave abnormalities
Eligibility Criteria
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).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | CTC Clinical Trial Consultants AB | Uppsala | Sweden | SE-75237 |
Sponsors and Collaborators
- Cinclus Pharma AG
Investigators
- Principal Investigator: Jian Fransén, MD, CTC Clinical Trial Consultants AB
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CX842A2104