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

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ClinicalTrials.gov Identifier: NCT01716234
Recruitment Status : Terminated (Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic data.)
First Posted : October 29, 2012
Results First Posted : April 15, 2016
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

October 25, 2012
October 29, 2012
March 15, 2016
April 15, 2016
August 27, 2018
April 17, 2008
April 1, 2015   (Final data collection date for primary outcome measure)
  • 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.
Average Plasma Concentration (Cavg) of Posaconazole at Steady State [ Time Frame: Day 1 and Day 7 ]
Complete list of historical versions of study NCT01716234 on ClinicalTrials.gov Archive Site
  • 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.
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 28 days ]
  • Number of Participants Discontinuing Study Treatment Due to an AE [ Time Frame: Up to 28 days ]
Not Provided
Not Provided
 
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fungal Infections
  • 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®
  • 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®
  • 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®
  • 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®
  • 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.
    Intervention: Drug: Posaconazole 12 mg/kg/day BID
  • 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.
    Intervention: Drug: Posaconazole 12 mg/kg/day BID
  • 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.
    Intervention: Drug: Posaconazole 18 mg/kg/day BID
  • 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.
    Intervention: Drug: Posaconazole 18 mg/kg/day BID
  • 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.
    Intervention: Drug: Posaconazole 18 mg/kg/day TID
  • 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.
    Intervention: Drug: Posaconazole 18 mg/kg/day TID
  • 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.
    Intervention: Drug: Posaconazole 12 mg/kg/day TID
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
142
108
April 1, 2015
April 1, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Months to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   Germany,   Greece,   Netherlands,   United States
 
NCT01716234
P03579
2007-004645-15 ( EudraCT Number )
MK-5592-032 ( Other Identifier: Merck )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP