Clinical Trial

A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults

Study acronym: APP
Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This is an open-label pharmacokinetic study in 24 healthy Thai participants. Participants will be admitted in the inpatient ward and each participant will attend a total of 4 visits, including one screening visit and three hospital admissions. Participants will be randomized into one of six groups. Each group will receive 3 drug regimens consisting of (1) piperaquine, (2) pyronaridine plus artesunate, or (3) piperaquine, pyronaridine, and artesunate, administered once per day for three consecutive days in different sequential orders. After each regimen, participants will be followed up for six weeks for clinical assessments and laboratory evaluations to study the pharmacokinetics. A washout period of at least eight weeks will be implemented between each regimen. This study is funded by the Global Health Innovative Technology Fund (GHIT Fund), Tokyo, Japan, under grant number G2025-117.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-06-01 -> 2027-11-01 2026-08-06
minor Completion pushed: 2027-08-01 -> 2027-11-01 2026-08-06
Trial Details
NCT Number NCT07470424
Lead Sponsor University of Oxford
Conditions Malaria
Enrollment 24 participants
Start Date 2026-11-01
Primary Completion 2027-11-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-05