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

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00608335

Purpose

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.

Condition	Intervention	Phase
Invasive Candidiasis Esophageal Candidiasis Oropharyngeal Candidiasis Candidemia	Drug: Micafungin	Phase I

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders Fungal Infections Molds Yeast Infections

Drug Information available for: FK 463 Micafungin

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Micafungin 3.0 mg: Experimental	Drug: Micafungin IV
2. Micafungin 4.5 mg: Experimental	Drug: Micafungin IV

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.

Eligibility

Ages Eligible for Study:	2 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608335

Contacts

Contact: Astellas Pharma Global Development

800-888-7704 ext 5473

clintrials.info@us.astellas.com

Locations

United States, California
	Recruiting
Orange, California, United States, 92868
	Recruiting
Los Angeles, California, United States, 90095
United States, Minnesota
	Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Missouri
	Recruiting
Kansas City, Missouri, United States, 64108
United States, North Carolina
	Recruiting
Durham, North Carolina, United States, 27710
United States, Oregon
	Recruiting
Portland, Oregon, United States, 97239
United States, Texas
	Recruiting
Dallas, Texas, United States, 75390
	Recruiting
Houston, Texas, United States, 77030
South Africa
	Terminated
Cape Town, South Africa, 7924
	Terminated
Benoni, South Africa, 1500
	Terminated
Mariannhill, South Africa, 3610
	Terminated
Lynn East, South Africa, 0039
	Terminated
Temba, South Africa, 0400
	Terminated
Wynberg, South Africa, 7824

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Astellas Pharma Global Development ( Sr Manager Clinical Trial Registry )
Study ID Numbers:	9463-CL-2101
Study First Received:	January 23, 2008
Last Updated:	November 10, 2009
ClinicalTrials.gov Identifier:	NCT00608335 History of Changes
Health Authority:	United States: Food and Drug Administration; South Africa: Medicines Control Council

Keywords provided by Astellas Pharma Inc:

Antifungal
Echinocandin
Candidiasis
Micafungin

Additional relevant MeSH terms:

Anti-Infective Agents
Mycoses
Digestive System Diseases
Candidiasis
Gastrointestinal Diseases

Therapeutic Uses
Antifungal Agents
Esophageal Diseases
Pharmacologic Actions
Micafungin

ClinicalTrials.gov processed this record on November 30, 2009