NCT05633147

Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam

Effect of Repeated Dosing of Clarithromycin on PK of Linaprazan Glurate/Linaprazan, Effect of Single Dose of Linaprazan Glurate on PK of Clarithromycin, Single/Repeated Dosing of Linaprazan Glurate on PK of Midazolam to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Cinclus Pharma Holding AB · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a phase I, open-label, fixed sequence design, drug-drug-interaction (DDI) study divided in 2 parts. Part I is designed to evaluate whether concomitant treatment with linaprazan glurate and clarithromycin, a strong inhibitor of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein P (PgP), leads to an effect on the systemic exposure to linaprazan glurate and linaprazan and whether there is an effect on the pharmacokinetics of clarithromycin after a single dose of linaprazan glurate. Part II is designed to evaluate the effect of repeated doses of linaprazan glurate on the pharmacokinetics (PK) of a sensitive substrate of CYP3A (midazolam).

Conditions

• Safety Issues
• Pharmacokinetics
• Drug Interaction
• Tolerability

Interventions

Type	Name	Description
DRUG	Linaprazan glurate	Investigational Medicinal Product: Linaprazan glurate (tablets). Part I: Linaprazan glurate in base form, 100 mg once daily Day 1 and Day 10. Part II: Linaprazan glurate hydrochloride (HCl), 75 mg twice daily for 13 days.
DRUG	Drug drug interaction (DDI) - Clarithromycin (Part I)	Index inhibitor (perpetrator drug) Clarithromycin 500 mg twice daily for 9 days (tablets).
DRUG	Drug drug interaction (DDI) - Midazolam (Part 2)	Substrate for CYP3A. Midazolam 2.5 mg once daily (2.5 mL oral solution).

Timeline

• Start date: 2022-11-27
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2022-12-01
• Last updated: 2025-01-03
• Results posted: 2025-01-03

Locations

1 site across 1 country: Sweden