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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 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 49 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03241550
The ClinicalTrials.gov registry entry for NCT03241550 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which isavuconazonium sulfate - intravenous is the first listed.
NCT03241550 reports 0 study locations.
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.
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