NCT07308041

A Study to Investigate the Effect of Linaprazan Glurate on the Pharmacokinetics of Amoxicillin

An Open, Single Arm, Single-center, Phase 1 Trial Investigating the Effect of 7-days-repeated Administration of Linaprazan Glurate on the Pharmacokinetics of Repeated Doses of Amoxicillin in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cinclus Pharma Holding AB · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is an open, single arm, single-center Phase I trial designed to evaluate the effect of seven days repeated oral doses of linaprazan glurate on the pharmacokinetics (PK) of repeated doses of amoxicillin in healthy male and female participants

Detailed description

Participants in the trial will attend three visits to the clinical research unit (CRU) and a telephone follow-up visit. Eligible participants will be admitted to the CRU in the evening of Day -1 and will remain at the CRU until the morning of Day 2 In the morning of Day 1, after pre-dose assessments, a dose of amoxicillin will be administered followed by 24 hours PK blood sampling for determination of amoxicillin plasma concentrations. Safety will be followed up throughout the 24 hours. In the morning of Day 2, after the 24-hour amoxicillin PK sample and safety assessments, the first linaprazan glurate will be administered to the participants. The participants will then continue to take linaprazan glurate (Day 2 to Day 8). The participants will be admitted to the CRU in the afternoon of Day 6 and will remain at the CRU until the morning of Day 9. PK samples for determination of linaprazan glurate and linaprazan in plasma will be collected for 24 hours at Day 7. In the morning of Day 8, the participants will be administered a new dose of amoxicillin together with the dose of linaprazan glurate, which will be followed by 24 hours PK sampling for determination of amoxicillin, linaprazan glurate and linaprazan plasma concentrations. The participants will leave the CRU after the 24-hour PK sample and safety assessments. A final end-of-trial telephone call will take place seven days (±two days) after the final dosing on Day 8.

Conditions

• Drug Interaction
• GERD (Gastroesophageal Reflux Disease)
• Safety, and Tolerability

Interventions

Type	Name	Description
DRUG	Drug Drug Interaction	The intervention phase consists of 2 periods: in period 1, the pharmacokinetics (PK) of amoxicillin will be evaluated in the absence of linaprazan glurate, in period 2, a potential effect of linaprazan glurate on the PK of amoxicillin will be evaluated as well as the PK of linaprazan glurate following co-administration of amoxicillin.

Timeline

• Start date: 2025-11-11
• Primary completion: 2025-12-22
• Completion: 2025-12-22
• First posted: 2025-12-29
• Last updated: 2026-02-27

Locations

1 site across 1 country: Sweden