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A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579 AM4)

This study is currently recruiting participants.
Verified April 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01716234
First received: October 25, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.


Condition Intervention Phase
Fungal Infections
 Drug: Posaconazole oral suspension
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Average Plasma Concentration (Cavg) of Posaconazole After Single Dose and at Steady State [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 58 days ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Treatment Due to an AE [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: April 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Age Groups 1 and 2

Posaconazole oral suspension 12 mg/kg/day divided into 2 (BID) or 18 mg/kg/day divided into 2 (BID) or 3 (TID) doses for up to 28 days:

Age Group 1: Participants aged 2 to <7 years

Age Group 2: Participants aged 7 to <18 years

 Drug: Posaconazole oral suspension
Posaconazole administered orally in 2 or 3 divided doses to participants stratified by age group
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®
Experimental: Age Group 3

Posaconazole oral suspension 12 mg/kg/day or 18 mg/kg/day divided into 3 (TID) doses for up to 28 days:

Age Group 3: Participants aged 3 months to <2 years

 Drug: Posaconazole oral suspension
Posaconazole administered orally in 2 or 3 divided doses to participants stratified by age group
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®

  Eligibility

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented or anticipated neutropenia expected to last at least 7 days and only in the following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia; autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT during the pre-engraftment (neutropenia) period
  • Participants of child-bearing potential must use a medically accepted method of contraception throughout the study and for at least 30 days after stopping study medication, unless they are surgically or medically sterile or agree to remain abstinent.

Exclusion Criteria:

  • Proven invasive fungal infection (IFI) before study entry
  • Severe nausea and/or vomiting at screening
  • Received posaconazole within 10 days before screening
  • Unable to receive study drug by mouth or via an intestinal (enteral) tube
  • Females who are pregnant, intend to become pregnant during the study, or are breastfeeding
  • History of anaphylaxis attributed to the azole class of antifungal agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716234

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, California
Call for Information (Investigational Site 0007) Recruiting
Orange, California, United States, 92868
United States, District of Columbia
Call for Information (Investigational Site 0003) Recruiting
Washington, District of Columbia, United States, 20010
United States, Maryland
Call for Information (Investigational Site 0021) Recruiting
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Call for Information (Investigational Site 0038) Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Call for Information (Investigational Site 0004) Recruiting
New Hyde Park, New York, United States, 11040
United States, Ohio
Call for Information (Investigational Site 0034) Recruiting
Cleveland, Ohio, United States, 44106
Call for Information (Investigational Site 0033) Recruiting
Toledo, Ohio, United States, 43606
United States, Oregon
Call for Information (Investigational Site 0037) Recruiting
Portland, Oregon, United States, 97239
United States, Rhode Island
Call for Information (Investigational Site 0047) Recruiting
Providence, Rhode Island, United States, 02903
United States, Washington
Call for Information (Investigational Site 0045) Recruiting
Seattle, Washington, United States, 98105
Canada, Quebec
Merck Frosst Canada Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Mauricio Ede     1-514-428-3044        
Germany
Merck Sharp & Dohme GmbH Recruiting
Haar, Germany
Contact: Kristian Lobner     49 89 4561 1102        
Greece
Vianex, S.A. / MSD Recruiting
Alimos, Greece
Contact: Platon Peristaris     30 2109897322        
Netherlands
Merck Sharp & Dohme BV Recruiting
Haarlem, Netherlands
Contact: Trea van der Galien     31-(0)23-5153153        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01716234     History of Changes
Other Study ID Numbers: P03579, 2007-004645-15, MK-5592-032
Study First Received: October 25, 2012
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycoses
Posaconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 23, 2013