Pharmacokinetics of OZ439 and piperaquine
Research type
Research Study
Full title
Open label study to investigate the pharmacokinetics of OZ439 and piperaquine following oral administration of OZ439 + TPGS granules for oral suspension alone or with either piperaquine phosphate tablets or piperaquine phosphate granules for oral solution in the fasted state in healthy volunteers.
IRAS ID
138604
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Medicines for Malaria Venture
Eudract number
2013-003409-25
Research summary
We are conducting a clinical study with a new medicine known as OZ439 in combination with an established medicine known as piperaquine phosphate (hereafter referred to as PQP) for treatment of malaria as described below. Malaria is a tropical disease spread by female Anopheles mosquitoes that are infected by Plasmodium parasites. If not diagnosed and treated promptly, malaria can be fatal. OZ439 is being developed by the Medicines for Malaria Venture (the sponsor company) to treat malaria in combination with other medicines such as PQP.
In this study we will give healthy volunteers specific formulations of both OZ439 and PQP in order to assess the impact on safety and pharmacokinetics (how the drugs are broken down in the body) when given together compared to giving OZ439 alone. The formulations will be given as tablet or drinking suspension as most malaria patients are young children who cannot swallow tablets. This will help us to determine suitable formulations and doses to give to patients in further clinical trials.
It is anticipated that 56 healthy male and female (of non-child bearing potential) volunteers will be included in the study. The study will take up to 73 days to complete, including the time before the study to determine if volunteers are eligible to participate, the conduct of the study and the follow-up examinations at the end of the study. Volunteers are required to attend a screening visit within 21 days before the admission day for the start of the study. Participation requires an in-patient period of 6 days (5 nights), a further 6 outpatient visits and a follow-up visit 50 days after the dosing.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0448
Date of REC Opinion
30 Sep 2013
REC opinion
Further Information Favourable Opinion