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

NCT05633147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-01-03

Study results available
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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

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).

Sponsors & Collaborators

  • Cinclus Pharma Holding AB

    lead INDUSTRY

Principal Investigators

  • Karin Palm · CTC Clinical Trial Consultants AB

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-27
Primary Completion
2023-05-30
Completion
2023-05-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05633147 on ClinicalTrials.gov