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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 25, 2012
Last updated: November 19, 2014
Last verified: November 2014

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:

Further study details as provided by Merck Sharp & Dohme Corp.:

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: June 2015
Estimated Primary Completion Date: June 2015 (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®


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01716234

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

United States, California
Call for Information (Investigational Site 0007) Recruiting
Orange, California, United States, 92868
Call for Information (Investigational Site 0023) Recruiting
San Diego, California, United States, 92120
United States, District of Columbia
Call for Information (Investigational Site 0003) Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Call for Information (Investigational Site 0046) Recruiting
Gainesville, Florida, United States, 32610
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, 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, Washington
Call for Information (Investigational Site 0045) Recruiting
Seattle, Washington, United States, 98105
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Medical Information Centre / Centre de l'information medicale de Merck Canada    514-428-8600 / 1-800-567-2594      
Merck Sharp & Dohme GmbH Recruiting
Haar, Germany
Contact: German Medical Information Center    49 800 673 673 673      
Vianex, S.A. / MSD Recruiting
Alimos, Greece
Contact: Platon Peristaris    30 2109897322      
Merck Sharp & Dohme BV Recruiting
Haarlem, Netherlands
Contact: Caroline Doornebos    31 23 515 3362      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01716234     History of Changes
Other Study ID Numbers: P03579, 2007-004645-15, MK-5592-032
Study First Received: October 25, 2012
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Trypanocidal Agents processed this record on November 25, 2014