Oral Posaconazole in subjects at risk of Invasive Fungal Infection

• Research type

  Research Study

• Full title

  Pharmacokinetics and Safety of Solid Oral Posaconazole (SCH 56592) in Subjects at High Risk for Invasive Fungal Infections (Phase 1b; Protocol No. P05615)

• IRAS ID

  37490

• Contact name

  Michael Neil Potter

• Sponsor organisation

  Schering-Plough Research Institute

• Eudract number

  2008-006684-36

• ISRCTN Number

  N/A

• Research summary

  BACKGROUND Posaconazole (POS) as an 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, a solid oral POS tablet has been developed to be administered without regard to food intake and achieve the same concentrations of the drug in the patients blood as the oral suspension when taken with food. The purpose of this study is to evaluate the amount of drug in the patient's blood (pharmacokinetics, PK) and to evaluate the safety of Oral POS. DESIGN This is a single arm, open-label (the Investigator and the patient know what drug dose the patient is receiving), multi-center study of the PK, safety and tolerability of solid oral POS tablet used as in prevention (prophylaxsis)in subjects at high risk of a IFIs. There are two parts to the study. Part 1, will assess tolerability and measure the level of POS in the patient's blood in approximately 18 patients after the plasma level of POS has reached a constant level (steady state). In part 2 approximately 200 patients with a low white blood cell count (Neutropenic) undergoing chemotherapy for Acute Myelogenous Leukemia(AML) or Myelodisplastic Syndrome (MDS ), or those with graft-versus-host disease (GVHD) will be evaluated. Patients will receive solid oral POS 200 mg twice a day on day 1 followed by 200 mg a day for up to 28 days. Subjects will participate for a maximum of 80 days, which includes Screening (day -7), study drug for 28 days, one follow up visit (day 30-35) and a survival assessment(day 65-70). The UK will participate in Part 2 only.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/17

• Date of REC Opinion

  21 Apr 2010

• REC opinion

  Further Information Favourable Opinion