Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug

This study has been completed.

Sponsor:

Information provided by:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00607763

First received: January 23, 2008

Last updated: December 3, 2010

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 23, 2008

Last Updated Date

December 3, 2010

Start Date ^ICMJE

October 2007

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of Micafungin pharmacokinetics [ Time Frame: 10 - 14 Days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00607763 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECTs and physical evaluation [ Time Frame: 13 - 17 Days ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug

Official Title ^ICMJE

A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis

Brief Summary

Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed

Detailed Description

This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Invasive Candidiasis
Esophageal Candidiasis
Oropharyngeal Candidiasis
Candidemia

Intervention ^ICMJE

Drug: Micafungin (Mycamine)

Other Name: FK463

Study Arm (s)

Experimental: 1. Micafungin

Intervention: Drug: Micafungin (Mycamine)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject is ≥4 months to < 24 months
Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables

Exclusion Criteria:

Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase > 5 times the upper limit of normal (ULN)
Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
Subject has received treatment with an echinocandin within one week prior to first dosing
Subject status is unstable and subject is unlikely to complete all study required procedures

Gender

Both

Ages

4 Months to 23 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00607763

Other Study ID Numbers ^ICMJE

9463-CL-2102

Has Data Monitoring Committee

Responsible Party

Sr Manager Clinical Trial Registry, Astellas Pharma Global Development

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Central Contact

Astellas Pharma Global Development

Information Provided By

Astellas Pharma Inc

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top