drugset / Trial / NCT05160363
A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate
Phase 1
Completed
37 enrolled
Medicines for Malaria Venture
PharmaKinetic Ltd · collabRichmond Pharmacology Limited · collab
RandomizedParallel-groupTriple-blindOther
Summary
The study is a clinical trial involving two medicines called piperaquine (PQP) and pyronaridine (PYR) which, in combination with dihydroartemisinin (DHA) and with artesunate (ART) respectively, have been in clinical use for over 20 years to treat acute episodes of malaria. PYR and PQP are both known to be well tolerated and provide effective treatment for malarial infection when administered in their licensed combinations, but have not been administered together in combination before. This new combination is being considered for development for malaria prevention (i.e. chemoprophylaxis) in sub-Saharan Africa and therefore, the trial participants will be exclusively drawn from a population from that origin.
Timeline
- Start
- 2022-02-14
- Primary completion
- 2022-05-31
- Completion
- 2022-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyronaridine | Unknown | 540 mg | Oral |
| Subject | Pyronaridine | Unknown | 720 mg | Oral |
| Subject | piperaquine | Small molecule | 960 mg | Oral |
| Subject | piperaquine | Small molecule | 1280 mg | Oral |
Indications
No indication recorded.