Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03241550 · ClinicalTrials.gov registry record · Phase 1
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT03241550: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT03241550 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03241550, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.
Primary Outcome
Maximum concentration at steady state (Cmax) will be derived from the PK plasma samples collected.
Interventions
- DRUG isavuconazonium sulfate - intravenous
- DRUG isavuconazonium sulfate - oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2017-10-02 |
| Est. Completion | 2019-07-05 |
| Phase | Phase 1 |
What the finished NCT03241550 record still lists
NCT03241550 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which isavuconazonium sulfate - intravenous is the first listed.
NCT03241550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03241550 about?
NCT03241550 is a clinical study titled "A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients". The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the ...
What is the current status of trial NCT03241550?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2017-10-02. Estimated completion is 2019-07-05.
What interventions are being tested in trial NCT03241550?
The interventions under investigation include: isavuconazonium sulfate - intravenous (DRUG), isavuconazonium sulfate - oral (DRUG).
Who is sponsoring clinical trial NCT03241550?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03241550's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02704858 · 49 participants · Phase 1
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
- NCT03516708 · 49 participants · Phase 1
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
- NCT03692429 · 49 participants · Phase 1
alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
- NCT04329494 · 49 participants · Phase 1
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI