NCT01383096

Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers

A Phase I Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess prototype formulations compared to the aqueous dispersion of Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is hoped that the bioavailability of OZ439 can be enhanced in the fasted state to be close to that observed when given after food. This will improve the utility of OZ439 in the field as well as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is very important for an antimalarial drug product destined for use in developing counties.

Detailed description

This study was a single centre, open-label, pharmacokinetic, randomized cross-over study in healthy male volunteers and post-menopausal women. This study was conducted over three different cohorts as follows: Cohort 1: Subjects received a single 800 mg (as free base) dose of five different treatment regimes (treatments A, B, C, D and E) on five occasions. Cohort 2: Subjects received a single 800 mg (as free base) dose of four different treatment regimes (treatments F, G, H and I) on four occasions. Cohort 3: Subjects received a single dose, 800mg (as free base) of prototype solution formulation 1 (treatment J) and 400mg (as free base) of prototype solution formulation 1 (treatment K) on two occasions. The treatments were administered under the fasted state.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	OZ439 mesylate 800mg Powder in Bottle for Oral Suspension	OZ439 800 mg (as free base) as powder in a bottle for reconstitution in a suspension prior to oral administration
DRUG	OZ439 mesylate 400mg Prototype Solution Formula 1	OZ439 400 mg (as free base) as a prototype solution formulation 1
DRUG	OZ439 mesylate 800mg Prototype Solution Formula 1	OZ439 800 mg (as free base) as a prototype solution formulation 1
DRUG	OZ439 mesylate 800mg Prototype Solution Formula 2	OZ439 800 mg (as free base) as a prototype solution formulation 2

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-06-28
• Last updated: 2015-01-29
• Results posted: 2015-01-29

Locations

1 site across 1 country: Australia