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Effectiveness of OZ439 as a Gametocytocidal and Transmission Blocking Agent

NCT02431650 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-05-26

Study results available
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Summary

This is a single-centre, controlled, open label study using P. falciparum-induced blood stage malaria (IBSM) infection to assess the effectiveness of OZ439 as a gametocytocidal agent, as well as its treatment effects on gametocyte infectivity and development in vector mosquitoes. Previous clinical studies including one IBSM study have shown that in addition to effectively clearing replicating, asexual (pathogenic) life cycle stages of malaria, a single dose of piperaquine (480 mg) results in the production of gametocytes, as determined by gametocyte-specific transcript (pfs25) qPCR. The propensity of piperaquine to induce gametocytaemia will be employed in this study to assess the efficacy of OZ439 as a gametocytocidal and transmission blocking agent. Experimental mosquito feeding via both direct feeding on participants and artificial (indirect) membrane mosquito feeding will be performed. The study will be conducted in up to 3 cohorts where participants will be randomised into an experimental or a control group (n=2 per group) when peak gametocytemia occurs (approximately 15 days after administration of piperaquine).

Conditions

Interventions

DRUG

OZ439

DRUG

Primaquine

Sponsors & Collaborators

  • Q-Pharm Pty Limited

    collaborator INDUSTRY

  • Clinical Network Services (CNS) Pty Ltd

    collaborator INDUSTRY

  • Sullivan Nicolaides Pathology

    collaborator INDUSTRY

  • QIMR Berghofer Medical Research Institute

    collaborator OTHER

  • Army Malaria Institute, Australia

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • James McCarthy, Prof · QIMR Berghofer Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT02431650 on ClinicalTrials.gov