NCT01660022

Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects

A Phase I Study to Investigate the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Piperaquine to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase I Study to investigate the safety, tolerability \& pharmacokinetics of co-administered single doses of OZ439 and Piperaquine to healthy subjects.

Detailed description

Placebo-controlled, double-blind, five-cohort, 2-period (per cohort) dose-escalation study. For each subject, the study included a screening evaluation (within 21 days of the 1st dose), dosing on 2 separate occasions (Period 1 and Period 2) and a follow-up visit (6 weeks following the final dose). Within each cohort, subjects were randomised into two sequences to receive OZ439 in Period 1 and OZ439 plus piperaquine in Period 2 (sequence 1, 8 subjects) or OZ439-matching placebo in Period 1 and OZ439/piperaquine matching placebos in Period 2 (sequence 2, 4 subjects). Safety and tolerability were evaluated: Physical examination, ECG assessments including a full baseline matched profile of ECG tracings, vital signs, laboratory evaluations, in particular liver function tests and adverse events.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	100mg OZ439 single oral dose	100mg OZ439 oral suspension single dose
DRUG	Placebo	Placebo
DRUG	300 mg OZ439 single oral dose	300mg OZ439 oral suspension single dose
DRUG	160mg Piperaquine single oral dose	160 mg Piperaquine tablet
DRUG	480mg Piperaquine single oral dose	480 mg Piperaquine tablet
DRUG	1440mg Piperaquine single oral dose	1440 mg Piperaquine tablet
DRUG	800 mg OZ439 single oral dose	800mg OZ439 oral suspension single dose

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-08-08
• Last updated: 2015-01-21
• Results posted: 2015-01-21

Locations

1 site across 1 country: Switzerland