Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP

Summary

A single-centre Phase 1b study to assess the safety, tolerability, pharmacokinetic profile, and antimalarial activity of single doses of coadministered artefenomel (OZ439) and piperaquine phosphate (PQP) against early Plasmodium falciparum blood stage infection in healthy adult volunteers.

Conditions

• Malaria

Interventions

DRUG

480 mg Piperaquine phosphate

480 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.

DRUG

640 mg Piperaquine phosphate

640 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.

DRUG

200 mg OZ 439

200 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension

DRUG

400 mg OZ 439

400 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension

DRUG

800 mg OZ 439

800 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension

DRUG

960 mg PQP

960 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.

DRUG

320 mg PQP

320 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.

Sponsors & Collaborators

• QIMR Berghofer Medical Research Institute

  collaborator OTHER

• Clinical Network Services (CNS) Pty Ltd

  collaborator INDUSTRY

• Q-Pharm Pty Limited

  collaborator INDUSTRY

• Medicines for Malaria Venture

  lead OTHER

Principal Investigators

• Rebecca Webster, Dr · QIMR Berghofer Medical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-04-23

Primary Completion

2019-04-19

Completion

2019-04-19

Countries

• Australia

Study Locations