Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug - Tabular View

Tracking Information

First Received Date ^ICMJE

January 23, 2008

Last Updated Date

September 2, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

PK parameters (AUCtau, Tmax, and Cmax) [ Time Frame: 10 - 14 Days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

PK parameters (AUC0-24, tmax, and Cmax) [ Time Frame: 10 - 14 Days ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00608335 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
Vital signs [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
Hematology and chemistry laboratory tests [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
12-lead ECGs and Physical examination [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Adverse events [ Time Frame: Day 1 to Day 17 (end of study visit) ] [ Designated as safety issue: No ]
Vital signs [ Time Frame: Day 1 to Day 17 (end of study visit) ] [ Designated as safety issue: No ]
Hematology and chemistry laboratory tests [ Time Frame: Day 1 to Day 17 (end of study visit) ] [ Designated as safety issue: No ]
12-lead ECGs and Physical examination [ Time Frame: Day 1 to Day 17 (end of study visit) ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

Study of Mycamine® in Children 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 Children (2-5 Years AND 6-11 Years) And Adolescents (12-16 Years) With Esophageal Candidiasis Or Other Invasive Candidiasis

Brief Summary

Children with fungal infections will be divided into two groups by weight. Children weighing < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing > 25 kg.

Detailed Description

This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's weight at baseline. Study procedures in both groups will be similar except that serial blood samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only participate in one group of the study.

A total of 24 subjects, 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12 in each of the three age ranges.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

Invasive Candidiasis
Esophageal Candidiasis
Oropharyngeal Candidiasis
Candidemia

Intervention ^ICMJE

Drug: Micafungin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2009

Estimated Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject is 2 to 16 years inclusive
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

2 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Astellas Pharma Global Development

800-888-7704 ext 5473

clintrials.info@us.astellas.com

Location Countries ^ICMJE

United States, South Africa

Administrative Information

NCT ID ^ICMJE

NCT00608335

Responsible Party

Sr Manager Clinical Trial Registry, Astellas Pharma Global Development

Study ID Numbers ^ICMJE

9463-CL-2101

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Central Contact

Astellas Pharma Global Development

Information Provided By

Astellas Pharma Inc

Verification Date

September 2009

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