Bioavailability and PK of OZ439 with Piperaquine phosphate (QCL117505)

• Research type

  Research Study

• Full title

  A Phase 1 Bioavailability Study of Selected Oral Prototype Granule Formulations of OZ439 in Healthy Subjects, to Evaluate the Pharmacokinetics of OZ439 when Co-Administered with Piperaquine Phosphate Tablets in the Fasted State

• IRAS ID

  172730

• Contact name

  Fiona Macintyre

• Sponsor organisation

  Medicines For Malaria Venture (MMV)

• Eudract number

  2015-000439-34

• Duration of Study in the UK

  0 years, 2 months, 20 days

• Research summary

  The Sponsor is developing the study drug, OZ439, for the potential treatment of malaria.

  The study will evaluate the pharmacokinetics (PK, how the body absorbs, distributes and gets rid of the drug) of different formulations of the study drug when co-administered with Piperaquine phosphate (PQP), an already marketed drug used in the treatment of malaria.

  The study will consist of two parts involving up to 48 healthy subjects in total. An interim decision will be made based on results from Part 1 to determine the study drug formulation and dose volume to be administered in Part 2.

• REC name

  Wales REC 1

• REC reference

  15/WA/0037

• Date of REC Opinion

  9 Mar 2015

• REC opinion

  Further Information Favourable Opinion