Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers Receiving a Seven Day Dose Regimen

Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers Receiving a Seven Day Dose Regimen

To investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers, receiving study drug over the course of 7 days.

The primary objective of this project is to investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers. Based on the results of this study, if one enantiomer seems to show a better safety profile (in terms of hematological effects), an analogous study will be carried out in G6PD deficient individuals (under a separate protocol). The studies are primarily aimed at understanding the tolerability and safety of the enantiomers in G6PD deficiency. If one shows a better safety profile, ultimately the evaluation of its efficacy will be required.

Inclusion Criteria:

• Normal, healthy adults aged 18 to 65 years

Exclusion Criteria:

• Known history of liver, kidney or hematological disease
• Known history of cardiac disease, Non Sinus Rhythm arrhythmia or QT prolongation
• Autoimmune disorders
• Report of an active infection
• Evidence of G6PD deficiency
• Participant is pregnant or breast-feeding, or is expecting to conceive during the study.