Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects

GERD Clinical Trial

Official title:

Ph 1, OL, Randomized, Parallel-group Study to Investigate PK and PD (Intragastric pH) of Linaprazan Glurate/Linaprazan After 14 Days Administration of Linaprazan Glurate to Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05742984
• Other study ID #: CX842A2107
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 26, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: January 2024
• Source: Cinclus Pharma Holding AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase I, single-center, open label parallel-group, randomized study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of single and repeated oral doses of Linaprazan Glurate for up to 14 days at 3 dose levels in healthy male and female subjects.

The subjects will be followed up to 28 days post IMP dosing.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: March 31, 2024
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.

2. Healthy male or female subject aged 18 to 65 years, inclusive.

3. Body mass index = 18.5 and = 30.0 kg/m2.

4. Medically healthy, without abnormal clinically significant medical history, physical findings, vital signs, ECGs, or laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

1. Female subjects of childbearing potential (defined as all subjects physiologically capable of becoming pregnant)

2. Male subjects with a partner of childbearing potential

3. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.

4. History of GERD or clinically significant acid reflux, as judged by the Investigator.

Related Conditions & MeSH terms

• GERD

Intervention

Drug:
• Linaprazan Glurate 25 mg
The participating subjects will receive 25 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
• Linaprazan Glurate 50 mg
The participating subjects will receive 50 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
• Linaprazan Glurate 75 mg
The participating subjects will receive 75 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.

Locations

Country	Name	City	State
Slovenia	CRS d.o.o,Ukmarjeva ulica 6	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Cinclus Pharma Holding AB

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	Area under the plasma concentration curve from 0 to infinity (AUCinf)	pre dose, 0,25 hours, 0,5 hours, 1 hour, 1,25 hours, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 20 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	AUC from time 0 to time 24 (AUC 0-24)	pre dose, 0,25 hours, 0,5 hours, 1 hour, 1,25 hours, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 20 hours, 24 hours
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	AUC from time 0 to time 12 (AUC 0-12)	pre dose, 0,25 hours, 0,5 hours, 1 hour, 1,25 hours, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	AUC from time 12 to time 24 (AUC 12-24)	12 hours, 14 hours, 20 hours, 24 hours
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	AUC from time 24 to time 48 (AUC 24-48)	24 hours, 36 hours and 48 hours
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	AUC from time 0 to time t (AUC 0-t)	pre dose, 0,25 hours, 0,5 hours, 1 hour, 1,25 hours, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 20 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	Trough plasma concentration (Ctrough)	pre dose, 0,25 hours, 0,5 hours, 1 hour, 1,25 hours, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 20 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	Maximum plasma concentration (Cmax)	pre dose, 0,25 hours, 0,5 hours, 1 hour, 1,25 hours, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 20 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	Average plasma concentration (Caver)	pre dose, 0,25 hours, 0,5 hours, 1 hour, 1,25 hours, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 20 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	Terminal elimination half life (t½)	pre dose, 0,25 hours, 0,5 hours, 1 hour, 1,25 hours, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 20 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Primary	Linaprazan Glurate and Linaprazan PK parameters after single and repeated administration of Linaprazan Glurate	Time of occurence of Cmax (Cmax (Tmax))	pre dose, 0,25 hours, 0,5 hours, 1 hour, 1,25 hours, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 20 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Primary	Linaprazan Glurate and Linaprazan PD parameters after single and repeated administration of Linaprazan Glurate	Percentage of time gastric pH > 4 at Day 1, and Day 14	48 hours at Day 1 and 48 hours at Day 14