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

This is a phase I, open-label, fixed 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).

Main Inclusion Criteria:Willing and able to give written informed consent for participation in the study.Healthy male and female subjects of non-childbearing potential aged 18 to 60 years, inclusive.Body mass index ≥ 18.0 and ≤ 30.0 kg/m2.Subjects as well as their partners, must agree to contraception requirements. Male subjects must refrain from donating sperm.Main Exclusion Criteria:Have known allergies to any components of the linaprazan glurate formulation, to clarithromycin/midazolam or to any drugs of a similar class including excipients associated with any of the drugs.Use of CYP3A4 inhibitors, antacids, PPIs or any medication that changes gastric pH.Use of any prescribed or non-prescribed CYP3A4-inducing medication or other metabolic enzyme inducers.History of any clinically significant disease or disorder defined in the protocol.