Comparison of the ECG Effects Related to Pharmacokinetic Profile of Chloroquine and Piperaquine
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
Chloroquine and piperaquine are the two most widely used antimalarial drugs ever. Hundreds of
millions of people have received these drugs. Both are structurally similar and have
cardiovascular effect. While there are no concerns over the use of chloroquine, regulatory
authorities have suggested restrictions on the use of piperaquine.
We have recently completed a series of cross-over clinical and pharmacokinetic evaluations of
chloroquine, piperaquine, pyronaridine and primaquine in healthy subjects. These studied were
approved by the ethical committee of FTM. All drugs were well tolerated with no clinically
significant ECG changes. Four subjects were in two studies. This offers a unique opportunity
to compare the electrocardiographic effects of chloroquine and piperaquine in the same
subjects and therefore characterize the concentration-effect relationships, and thus relative
safety.
We propose to extend the previous subject study to recruit 16 subjects including those who
have received either piperaquine or chloroquine in our previous studies so that 20 subjects
received both drugs for a crossover comparison. The blood sampling schedule and
electrocardiograms would be exactly the same as previously but would finish at 24 hours.