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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00607763

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Invasive Candidiasis Esophageal Candidiasis Oropharyngeal Candidiasis Candidemia	Drug: Micafungin (Mycamine)	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. Micafungin	Drug: Micafungin (Mycamine) IV Other Names: FK463

Arm

Intervention/Treatment

Experimental: 1. Micafungin

Drug: Micafungin (Mycamine)

Other Names:

FK463

Outcome Measures

Primary Outcome Measures

Evaluation of Micafungin pharmacokinetics [10 - 14 Days]

Secondary Outcome Measures

Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation [Day 1 to End of Study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Months to 23 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Los Angeles	California	United States	90095
2	Orange	California	United States	92868
3	Louisville	Kentucky	United States	40202
4	Kansas City	Missouri	United States	64108
5	Dallas	Texas	United States	75390
6	Houston	Texas	United States	77030