A PK/PD Study of Pyronaridine in Healthy Adult Participants Infected With Blood Stage Malaria
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is an open-label, adaptive study that will utilise the P. falciparum induced blood stage
malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile of
pyronaridine. Up to 18 healthy, malaria naïve adult participants are planned to be enrolled
into this study, in cohorts of up to six participants each. Following a screening period of
up to 28 days, cohorts of up to 6 healthy participants will be enrolled. Each participant
will be inoculated intravenously on Day 0 with P. falciparum infected erythrocytes.
Participants will be followed up daily on Days 1 to 3, and will attend the clinical unit once
on Days 4, 5, 6 and 7 for clinical evaluation and blood sampling. Participants will be
admitted to the clinical trial unit on Day 8 for a single oral dose of pyronaridine.
Different doses of pyronaridine will be administered across and within cohorts. Participants
will be randomised to a dose group on the day of dosing. The highest dose of pyronaridine
administered will be no more than 720 mg; the lowest dose administered will be no less than
180 mg.
Each subsequent cohort will be composed of up to 3 dose groups. The Safety Data Review Team
(SDRT) will review all available safety and tolerability data from the previous cohort/s
prior to inoculation of the next cohort.
Participants will be confined in the clinical unit for at least 96 h (Days 8 - 12) to monitor
the safety and tolerability of pyronaridine dosing. Upon discharge from the clinical unit
participants will be monitored on an outpatient basis up to Day 50±2. Participants will
receive compulsory antimalarial rescue treatment with Riamet® (artemether/lumefantrine) on
Day 47±2 or earlier.
Phase:
Phase 1
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
Children's Health Queensland Hospital and Health Service QIMR Berghofer Medical Research Institute Southern Star Research Swiss BioQuant A.G., Switzerland