NCT01713608

A Dose-escalation Study to Investigate Safety and Toleration of OZ439

A Randomised, Placebo-controlled, Dose-escalation Study to Investigate Safety and Toleration of OZ439 OD for 3 Days to Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims: * To determine the safety and tolerability of ascending doses of OZ439 OD for three days. * To assess pharmacokinetic parameters of ascending doses of OZ439 given OD. * To identify the maximum tolerated dose of OZ439 administered.

Detailed description

This study will be conducted in a randomised, placebo-controlled dose-escalation design with OZ439 OD administered with full fat milk for three days to healthy male and female subjects between 18 to 55 years of age, using features of an adaptive study design. The study is expected to have three cohorts with a total of 36 healthy male and female subjects. An additional two cohorts may be used if required. The results of this study will inform the maximum tolerated exposure of OZ439 following OD dosing for three days in subjects who are not fasted.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	OZ439	OZ439 x mg once daily for 3 days with milk

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-10-25
• Last updated: 2015-03-23
• Results posted: 2015-03-23

Locations

1 site across 1 country: United Kingdom