Safety and toleration of OZ439 OD administered for 3 days

• Research type

  Research Study

• Full title

  A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers

• IRAS ID

  117541

• Contact name

  Ulrike Lorch

• Sponsor organisation

  Medicines for Malaria Venture

• Eudract number

  2012-004187-22

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  We are conducting a clinical study with a new medicine known as OZ439 at Richmond Pharmacology Ltd (RPL) clinical research unit. OZ439 is being developed by Medicines for Malaria Venture (the sponsor company; hereafter referred to as MMV) to treat Malaria, which is a tropical disease spread by female Anopheles mosquitoes that are infected by Plasmodium parasites. If not treated promptly, malaria can be fatal and there is increasing resistance to conventional drugs. OZ439 has been administered as a single dose with milk in previous clinical trials and it was found that milk increased the exposure (levels of OZ439 in the blood) by 2-3 fold compared to fasted volunteers. The increased exposure of OZ439 with milk may be high enough to treat malaria; using safe dose levels. OZ439 is being developed as a 'single dose cure' but it may be given as a 3 day treatment in some cases. In a previous study, doses of up to 800 mg in the fasted state were well tolerated. The aim of this study is to assess the exposure, safety and tolerability of OZ439 when given with milk to at least 36 volunteers for 3 days. Standard safety assessments will be conducted including standard laboratory safety tests (haematology, biochemistry, coagulation and urinalysis), vital signs, physical examinations, ECG, and pharmacokinetics. The study will take up to 38 days to complete, including the time before the study to determine eligibility of volunteers, the conduct of the study and the follow-up examinations at the end of the study. Volunteers will be required to attend a screening visit within 21 days before the start of the study. Participation requires 1 in-patient period of 7 days (6 nights), 2 further outpatient visits and a follow-up visit 14 days after dosing. The in-house stay may be extended if necessary for volunteers safety.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/1616

• Date of REC Opinion

  30 Oct 2012

• REC opinion

  Favourable Opinion