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

Cinclus Pharma

Status and phase: Completed; Phase 1

Conditions: Safety Issues; Tolerability; Drug Interaction; Pharmacokinetics

Treatments: Drug: Linaprazan glurate; Drug: Drug drug interaction (DDI) - Midazolam (Part 2); Drug: Drug drug interaction (DDI) - Clarithromycin (Part I)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05633147

CX842A2105

Details and patient eligibility

About

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).

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.
2. Healthy male and female subjects of non-childbearing potential aged 18 to 60 years, inclusive.
3. Body mass index ≥ 18.0 and ≤ 30.0 kg/m2.
4. Subjects as well as their partners, must agree to contraception requirements. Male subjects must refrain from donating sperm.

Main Exclusion Criteria:

1. 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.
2. Use of CYP3A4 inhibitors, antacids, PPIs or any medication that changes gastric pH.
3. Use of any prescribed or non-prescribed CYP3A4-inducing medication or other metabolic enzyme inducers.
4. History of any clinically significant disease or disorder defined in the protocol.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

35 participants in 1 patient group

linaprazan glurate

Experimental group

Description:

Part I: Linaprazan glurate in base form, 100 mg once daily will be administered under fasting conditions at day 1 and day 10. Part II: Linaprazan glurate hydrochloride (HCl), 75 mg twice a day for 13 days. The morning dose will be administered under fasting conditions on Day 2 and Day 14.

Treatment:

Drug: Drug drug interaction (DDI) - Clarithromycin (Part I)

Drug: Drug drug interaction (DDI) - Midazolam (Part 2)

Drug: Linaprazan glurate