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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-27

Study Completion Date

2023-05-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Safety Issues Pharmacokinetics Drug Interaction Tolerability

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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linaprazan glurate

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.

Group Type EXPERIMENTAL

Linaprazan glurate

Intervention Type DRUG

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 interaction (DDI) - Clarithromycin (Part I)

Intervention Type DRUG

Index inhibitor (perpetrator drug) Clarithromycin 500 mg twice daily for 9 days (tablets).

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

Intervention Type DRUG

Substrate for CYP3A. Midazolam 2.5 mg once daily (2.5 mL oral solution).

Interventions

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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.

Intervention Type DRUG

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

Index inhibitor (perpetrator drug) Clarithromycin 500 mg twice daily for 9 days (tablets).

Intervention Type DRUG

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

Substrate for CYP3A. Midazolam 2.5 mg once daily (2.5 mL oral solution).

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes