Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers Receiving a Seven Day Dose Regimen
Malaria, Glucose 6 Phosphate Dehydrogenase Deficiency
About this trial
This is an interventional basic science trial for Malaria focused on measuring Hemolysis, Primaquine, Pharmacokinetics
Eligibility Criteria
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.
Sites / Locations
- University of Mississippi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Placebo Comparator
RPQ (-) enantiomer
SPQ (+) enantiomer
Primaquine Phosphate
Placebo
Cohort 1 will receive 15 mg of RPQ (3A) every day for 7 days Cohort 2 will receive 22.5 mg of RPQ (3A) every day for 7 days
Cohort 1 will receive 15 mg of SPQ (2A) every day for 7 days Cohort 2 will receive 22.5 mg of SPQ (2A) every day for 7 days
Cohort 1 will receive 30 mg of RSPQ (1A) every day for 7 days Cohort 2 will receive 45 mg of RSPQ (1A) every day for 7 days
Cohort 1 will receive placebo (4A) capsules everyday for seven days Cohort 2 will receive placebo (4A) capsules everyday for seven days