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A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001

NCT04166669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-05-17

No results posted yet for this study

Summary

This is a Phase 1, open-label study to evaluate the drug-drug interaction potential of a strong CYP3A4 inhibitor (itraconazole) and a pan-CYP inducer (rifampin) on APX001 in two parallel groups of healthy subjects.

Conditions

Interventions

DRUG

APX001

Cohort 1 Day 1: APX001 500 mg IV BID over a 3-hour infusion; Day 18: APX001 500 mg IV BID over a 3-hour infusion. Cohort 2 Day 1: APX001 1000 mg IV BID over a 3-hour infusion; Day 24: APX001 1000 mg IV BID over a 3-hour infusion.

DRUG

Itraconazole

Cohort 1 Days 15-30: itraconazole 200 mg oral solution QD.

DRUG

Rifampin

Cohort 2 Days 15-33: rifampin 600 mg oral QD.

Sponsors & Collaborators

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Marc Engelhardt · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2020-03-03
Completion
2020-03-03
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

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 NCT04166669 on ClinicalTrials.gov