Product
APX001
Aliases
fosmanogepix
7 clinical trials
6 indications
Indication
Fungal InfectionIndication
CandidemiaIndication
invasive candidiasisIndication
CandidiasisIndication
Acute Myeloid LeukemiaIndication
Invasive Fungal InfectionsClinical trial
A Phase 1, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of APX001, to Investigate the Effect of Food on APX001 and to Investigate the Drug-Drug Interaction Potential of APX001Status: Completed, Estimated PCD: 2017-04-20
Clinical trial
A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of APX001 to Evaluate the Effects of CYP3A4 Inhibition and Pan-CYP Induction in Two Parallel Groups of Healthy Male and Female SubjectsStatus: Completed, Estimated PCD: 2020-03-03
Clinical trial
An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Patients With Candidemia and/or Invasive Candidiasis Caused by Candida AurisStatus: Completed, Estimated PCD: 2020-11-30
Clinical trial
An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non Neutropenic Patients With Candidemia, With or Without Invasive Candidiasis, Inclusive of Patients With Suspected Resistance to Standard of Care Antifungal TreatmentStatus: Completed, Estimated PCD: 2020-03-31
Clinical trial
A First-in-Human, Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy SubjectsStatus: Completed, Estimated PCD: 2017-07-03
Clinical trial
An Open Label, Multi-Center Study to Determine the Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia With NeutropeniaStatus: Completed, Estimated PCD: 2018-10-26
Clinical trial
A 3-Treatment, 3-Period, 6-Sequence Randomized Crossover Single-Dose Study Evaluating the Bioequivalence of High-Load and Low-Load Oral Tablet Formulations of Apx001 and the Effect of Food on the Absorption of Apx001 From the High-Load Tablet In Healthy SubjectsStatus: Completed, Estimated PCD: 2021-05-13