Clinical Trial: Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) and Powder for Oral Suspension Formulations of Posaconazole (POS) in Immunocompromised Pediatric Subjects With Neutropenia

Brief Summary: This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered intravenously (IV) or orally to immunocompromised pediatric participants.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Area under the plasma concentration versus time curve (AUC) for POS [ Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation at pre-dose and 4, 6, 8, 12, 24 hours post-infusion ]
  • Maximum plasma concentration (Cmax) for POS [ Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation at pre-dose and 4, 6, 8, 12, 24 hours post-infusion ]
  • Minimum plasma concentration (Cmin) for POS [ Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation at pre-dose and 4, 6, 8, 12, 24 hours post-infusion ]
  • Average steady-state plasma concentration (Cavg) for POS [ Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation at pre-dose and 4, 6, 8, 12, 24 hours post-infusion ]
  • Time of maximum plasma concentration (Tmax) for POS [ Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation at pre-dose and 4, 6, 8, 12, 24 hours post-infusion ]
  • Total body clearance (CL) for POS [ Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation at pre-dose and 4, 6, 8, 12, 24 hours post-infusion ]
  • Apparent total body clearance (CL/F) for POS [ Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation at pre-dose and 4, 6, 8, 12, 24 hours post-infusion ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: May 20, 2015
Date Started: September 7, 2015
Date Completion: December 16, 2017
Last Updated: May 15, 2017
Last Verified: May 2017