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NCT02059590 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02059590 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 6 participants.
The verdict
NCT02059590, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of BAL8728 in human plasma, urine and/or feces after a single intravenous dose of pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815. Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled isavuconazonium sulfate will also be evaluated.
Interventions
- DRUG Pyridinylmethyl-14C-labeled isavuconazonium sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-04 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02059590
The ClinicalTrials.gov registry entry for NCT02059590 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 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 1 intervention - of which Pyridinylmethyl-14C-labeled isavuconazonium sulfate is the first listed.
NCT02059590 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02059590 about?
NCT02059590 is a clinical study titled "A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects". The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled prodrug isavuconazonium...
What is the current status of trial NCT02059590?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-04. Estimated completion is 2013-04.
What interventions are being tested in trial NCT02059590?
The interventions under investigation include: Pyridinylmethyl-14C-labeled isavuconazonium sulfate (DRUG).
Who is sponsoring clinical trial NCT02059590?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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