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

NCT01383096 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2015-01-29

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Nucleus Network Ltd

    collaborator OTHER

  • Syneos Health

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Peter Peter Hodsman, MD · AMREP Centre for Clinical Studies, Nucleus Network, 89 Commercial Road, Melbourne, VIC 3004 Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01383096 on ClinicalTrials.gov