Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Candidiasis; Esophageal Candidiasis; Oropharyngeal Candidiasis; Candidemia
Intervention: Micafungin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Astellas Pharma Global Development
Overall contact:
Astellas Pharma Global Development, Phone: 800-888-7704, Ext: 5473, Email: clintrials.info@us.astellas.com
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
Clinical Details
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 design: Other, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Evaluation of Micafungin pharmacokinetics
Secondary outcome: Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation
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.
Eligibility
Minimum age: 4 Months.
Maximum age: 23 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subject is ≥4 months to < 24 months
2. Subject has suspected, proven or probable candidiasis, candidemia or other invasive
candidiasis
3. Subject has sufficient venous access to permit administration of study medication,
collection of pharmacokinetic samples, and monitoring of laboratory safety variables
Exclusion Criteria:
1. 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)
2. Subject has a concomitant medical condition that in the opinion of the investigator
and/or medical monitor precludes enrollment into the study
3. Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to
the echinocandin class of antifungals
4. Subject has received treatment with an echinocandin within one week prior to first
dosing
5. Subject status is unstable and subject is unlikely to complete all study required
procedures
Locations and Contacts
Astellas Pharma Global Development, Phone: 800-888-7704, Ext: 5473, Email: clintrials.info@us.astellas.com
Orange, California 92868, United States; Recruiting
Los Angeles, California 90095, United States; Recruiting
Louisville, Kentucky 40202, United States; Recruiting
Kansas City, Missouri 64108, United States; Recruiting
Dallas, Texas 75390, United States; Recruiting
Houston, Texas 77030, United States; Recruiting
Additional Information
Starting date: October 2007
Ending date: October 2009
Last updated: September 2, 2009
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