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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00608335
• Date of registration: 23/01/2008
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Inc
• Public title: Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
• Scientific title: 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
• Date of first enrolment: October 14, 2007
• Target sample size: 84
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00608335
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

South Africa, United States

Contacts

• Name: Senior Medical Director
• Affiliation: Astellas Pharma Global Development

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject is 2 to 16 years inclusive

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



Age minimum: 2 Years
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Oropharyngeal Candidiasis

Invasive Candidiasis

Esophageal Candidiasis

Candidemia

Intervention(s)

Drug: Micafungin

Primary Outcome(s)

PK parameters (AUCtau, Tmax, and Cmax) [Time Frame: 10 - 14 Days]

Secondary Outcome(s)

Hematology and chemistry laboratory tests [Time Frame: Day 1 to End of Study]

Adverse events [Time Frame: Day 1 to End of Study]

Vital signs [Time Frame: Day 1 to End of Study]

12-lead ECGs and Physical examination [Time Frame: Day 1 to End of Study]

Secondary ID(s)

9463-CL-2101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors