Posaconazole(IV)Study in Subjects at Risk of Invasive Fungal Infection

• Research type

  Research Study

• Full title

  Pharmacokinetics, Safety,and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension(SCH 56592)in Subjects at High Risk for Invasive Fungal Infections

• IRAS ID

  22029

• Contact name

  Samir Agrawal

• Sponsor organisation

  Schering-Plough Research Institute

• Eudract number

  2008-000235-18

• ISRCTN Number

  N/A

• Research summary

  BACKGROUNDPosaconazole(POS)oral suspension is approved in the UK for prophylaxis (prevention) of Invasive Fungal Infections (IFIs) in adult patients at risk of developing IFIs and in stem cell transplant patients at risk of rejecting their graft (graft-versus-host-disease,GVHD).Absorption of oral POS suspension is lower in fasting or in patients with limited oral food intake. To address the latter, an intravenous (IV) Posaconazole has been developed. The purpose of this study is to measure the amount of drug in the patient's blood (PK- Pharmacokinetics) and to evaluate the safety and tolerability of this IV formulation of Posaconazole.DESIGNA multi-centre, International study to be conducted at approximately 48 centres. This is a randomized open label study, all patients will receive Posaconazole. The study is divided into 4 cohorts (groups),approximately 250 subjects. The dose for cohort 3 will be selected from cohort 1 or 2. The UK will participate in group 3. IV drug administration either via a central or peripheral line. Decision cohort 0.Group 0:Single 200mg IV dose of POS or Placebo, followed by 400mg POS twice daily(BID)11 additional doses. Group 1:Day 1: 200mgIV POS(BID),followed by 200mg IV once daily (OD) day 2 to day 14. Group 2:Day 1: 300mgIV POS BID, followed by 300mg IV OD day 2 to day 14.Subjects in cohorts 1 & 2 will receive 400mg Posaconazole orally BID on day 15 to day 28.Group 3:Day 1: 200mg or 300mg BID,IV POS(dose selected from group 1 or 2) followed by either 200mg/day or 300mg/day IV once daily day 2 to day 5. Followed by randomisation to 200mg POS orally TID or 400mg POS Orally BID on days 6 to day 28. Subjects will participate for a maximum of 80 days, which includes Screening (day -7), study drug for 28 days, one follow up visit and a survival assessment.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/77

• Date of REC Opinion

  18 Nov 2010

• REC opinion

  Further Information Favourable Opinion