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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01716234
First received: October 25, 2012
Last updated: August 5, 2015
Last verified: August 2015
  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:


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 ]

Enrollment: 142
Study Start Date: April 2008
Study Completion Date: April 2015
Primary Completion Date: April 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®

  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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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: August 5, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycoses
Posaconazole
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

ClinicalTrials.gov processed this record on September 01, 2015