NCT02957929View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

April 20, 2017

Study Completion Date

April 20, 2017

Conditions
Fungal Infection
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

Trial Locations (2)

9728 NZ

PRA Health Sciences (PRA) - Early Development Services (EDS), Groningen

Unknown

PRA Health Sciences, Groningen

Sponsors
All Listed Sponsors
lead

Basilea Pharmaceutica

INDUSTRY