Comparative Bioavailability of OZ439 in Healthy Subjects (QBR114112)

• Research type

  Research Study

• Full title

  Three-Way Randomised Cross-Over Study in Healthy Subjects to Compare the Relative Bioavailability of Nanoparticulate OZ439 Delivered via the Enterion™ Capsule to the Proximal Small Bowel with Orally Administered OZ439 as PIB Suspension and Orally Administered Nanoparticulate

• IRAS ID

  115600

• Contact name

  Stuart J Mair

• Sponsor organisation

  Medicines for Malaria Venture (MMV)

• Eudract number

  2012-003769-17

• Research summary

  The Sponsor is developing the study drug, OZ439, as a potential anti-malarial treatment. The study will try to identify the comparative bioavailability of the study drug as the current powder-in-bottle (PIB) formulation, as an oral nanoparticulate formulation and as a nanoparticulate caplet delivered to the proximal small bowel via an Enterion capsule. This study will dose OZ439 orally to healthy male and female subjects, with each subject receiving 3 dose regimens in a randomised cross-over design. In Regimen A, the subjects will be dosed with 120 mg of OZ439 as a Powder in Bottle (PIB) formulation. In Regimen B, they will be dosed with 120 mg of OZ439 immediate release (IR) caplet formulation containing nanoparticulate. In Regimen C, they will be dosed with 120 mg of OZ439 caplet formulation containing nanoparticulate, administered orally via an Enterion capsule and delivered to the proximal small bowel.

• REC name

  Scotland A REC

• REC reference

  12/SS/0187

• Date of REC Opinion

  7 Nov 2012

• REC opinion

  Further Information Favourable Opinion