A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Phase of Trial: Phase I
Latest Information Update: 10 Dec 2018
At a glance
- Drugs Isavuconazonium (Primary) ; Isavuconazonium (Primary)
- Indications Haematological malignancies
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Astellas Pharma Global Development
- 12 Jun 2018 The study protocol has been amended to investigate additional form (oral capsule) of Isavuconazonium. Treatment arms, endpoints and subjects inclusion-exclusion criteria amended accordingly.
- 12 Jun 2018 Planned number of patients changed from 36 to 60.
- 12 Jun 2018 Planned End Date changed from 1 Mar 2019 to 1 Dec 2019.