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

Browse trials for

• Mycoses 539

Mycoses

539 studies on the registry are indexed under Mycoses; 55 are open to participants now.

This study's enrollment of 142 is above the median of 46 across 358 interventional studies indexed under Mycoses.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Interventions

• DrugPosaconazole 12 mg/kg/day BID

  Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)

  Also known as: SCH 056592, MK-5592, Noxafil®

• DrugPosaconazole 18 mg/kg/day BID

  Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)

  Also known as: SCH 056592, MK-5592, Noxafil®

• DrugPosaconazole 18 mg/kg/day TID

  Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)

  Also known as: SCH 056592, MK-5592, Noxafil®

• DrugPosaconazole 12 mg/kg/day TID

  Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day)

  Also known as: SCH 056592, MK-5592, Noxafil®

Primary outcomes

1. Average Concentration of Posaconazole (Cavg) on Day 1 (Single 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 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.

   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)

2. Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)

   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.

   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

Secondary outcomes

1. Number of Participants With an Adverse Event

   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.

   Time frame: Up to Day 58

2. Number of Participants With an Adverse Event Leading to Study Drug Discontinuation

   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.

   Time frame: Up to Day 28

Baseline characteristics

Publications

• Arrieta AC, Sung L, Bradley JS, Zwaan CM, Gates D, Waskin H, Carmelitano P, Groll AH, Lehrnbecher T, Mangin E, Joshi A, Kartsonis NA, Walsh TJ, Paschke A. A non-randomized trial to assess the safety, tolerability, and pharmacokinetics of posaconazole oral suspension in immunocompromised children with neutropenia. PLoS One. 2019 Mar 26;14(3):e0212837. doi: 10.1371/journal.pone.0212837. eCollection 2019. PubMed 30913226 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf