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

This study has been terminated.
(Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic data.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716234
First Posted: October 29, 2012
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 12 mg/kg/day BID Drug: Posaconazole 18 mg/kg/day BID Drug: Posaconazole 18 mg/kg/day TID Drug: Posaconazole 12 mg/kg/day TID Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Concentration of Posaconazole (Cavg) on Day 1 (Single Dose) [ Time Frame: Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups) ]
    Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to <2 years of age weighing <6.5 kg.

  • Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State) [ Time Frame: Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose ]
    Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to <2500 ng/mL.


Secondary Outcome Measures:
  • Number of Participants With an Adverse Event [ Time Frame: Up to Day 58 ]
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.

  • Number of Participants With an Adverse Event Leading to Study Drug Discontinuation [ Time Frame: Up to Day 28 ]
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.


Enrollment: 142
Actual Study Start Date: April 17, 2008
Study Completion Date: April 1, 2015
Primary Completion Date: April 1, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POS 12 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 12 mg/kg/day BID
Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®
Experimental: POS 12 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 12 mg/kg/day BID
Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®
Experimental: POS 18 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 18 mg/kg/day BID
Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®
Experimental: POS 18 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 18 mg/kg/day BID
Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®
Experimental: POS 18 TID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 18 mg/kg/day TID
Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®
Experimental: POS 18 TID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 18 mg/kg/day TID
Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®
Experimental: POS 12 TID 3 months to <2 Years
Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 12 mg/kg/day TID
Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day)
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716234


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01716234     History of Changes
Other Study ID Numbers: P03579
2007-004645-15 ( EudraCT Number )
MK-5592-032 ( Other Identifier: Merck )
First Submitted: October 25, 2012
First Posted: October 29, 2012
Results First Submitted: March 15, 2016
Results First Posted: April 15, 2016
Last Update Posted: May 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Mycoses
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs