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

Study Overview
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Brief Summary
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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
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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. At least 24 subjects, with at least 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.

Official Title
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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

Conditions
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Oropharyngeal Candidiasis, Candidemia, Invasive Candidiasis, Esophageal Candidiasis

Intervention / Treatment
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* Drug: Micafungin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Micafungin 3.0 mg<br>IV | Drug: Micafungin<br>* IV<br>* Other names: FK463;|
| Experimental: 2. Micafungin 4.5 mg<br>IV | Drug: Micafungin<br>* IV<br>* Other names: FK463;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters (AUCtau, Tmax, and Cmax) |  | 10 - 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Day 1 to End of Study | 
| Vital signs |  | Day 1 to End of Study | 
| Hematology and chemistry laboratory tests |  | Day 1 to End of Study | 
| 12-lead ECGs and Physical examination |  | Day 1 to End of Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antifungal, Micafungin, Echinocandin, Candidiasis