NCT04166669 - A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 12, 2019

Primary Completion Date

March 3, 2020

Study Completion Date

March 3, 2020

Conditions

Fungal Infection

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.

Trial Locations (2)

9728 NZ

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

Unknown

PRA-EDS, Groningen