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Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally

NCT02957929 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-09-10

No results posted yet for this study

Summary

This is a Phase l double-blind, placebo-controlled, randomized study to investigate the safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of APX001 administered intravenously and orally, followed by an evaluation of the safety, tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of APX001 administered orally.

Conditions

Interventions

DRUG

APX001 single IV dose

DRUG

APX001 single oral dose 1

DRUG

APX001 single oral dose 2

DRUG

APX001 single oral dose 3

DRUG

APX001 single oral dose fasted

DRUG

APX001 single oral dose fed

DRUG

APX001 multiple oral doses 1

DRUG

APX001 multiple oral doses 2

DRUG

APX001 multiple oral doses 3

DRUG

Cytochrome P450 substrates

DRUG

Matching placebo control

Sponsors & Collaborators

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Marc Engelhardt · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-04-20
Completion
2017-04-20

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

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 NCT02957929 on ClinicalTrials.gov