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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.

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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

FieldValue
Enrollment Target 49 participants
Start Date 2017-10-02
Est. Completion 2019-07-05
Phase Phase 1

Sponsor

Astellas Pharma Global Development

168 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.