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NCT01813461 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects

A Phase 1 study of Healthy Subjects and Pharmacokinetics of 14C-labeled Isavuconazole, sponsored by Astellas Pharma Global Development.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target
1
Study location

NCT01813461 is a Phase 1 study of Healthy Subjects and Pharmacokinetics of 14C-labeled Isavuconazole that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 8 participants, below the 129-participant average among 69 other Healthy Subjects trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01813461, a Phase 1 study of Healthy Subjects and Pharmacokinetics of 14C-labeled Isavuconazole, has completed, sponsored by Astellas Pharma Global Development.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.

Interventions

  • DRUG 14C-labeled prodrug isavuconazonium sulfate

Study Locations (1)

Wisconsin

  • Covance - Madison

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2012-10
Est. Completion 2012-11
Phase Phase 1

Sponsor

Astellas Pharma Global Development

168 total trials

What the Registry Record Tells You About NCT01813461

The ClinicalTrials.gov registry entry for NCT01813461 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129-participant average among 69 other Healthy Subjects trials with a reported enrollment target (94% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention - of which 14C-labeled prodrug isavuconazonium sulfate is the first listed.

NCT01813461 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT01813461 about?

NCT01813461 is a clinical study titled "Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects". The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.

What is the current status of trial NCT01813461?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2012-10. Estimated completion is 2012-11.

What conditions does trial NCT01813461 study?

This clinical trial studies the following conditions: Healthy Subjects, Pharmacokinetics of 14C-labeled Isavuconazole.

What interventions are being tested in trial NCT01813461?

The interventions under investigation include: 14C-labeled prodrug isavuconazonium sulfate (DRUG).

Who is sponsoring clinical trial NCT01813461?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01813461 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.