Genetic Variability in CYP2D6 in U.S Active Duty Population

Exclusion Criteria

• •Use of any investigational or non-registered drug within 30 days preceding the primaquine dosing.
• •Pregnant (positive urine β-HCG) or nursing at screening or plans to become pregnant or nurse from the time of enrollment until 48 hours after primaquine dosing.
• •Allergy to primaquine
• •Use of medications known to cause drug interactions with primaquine or CYP2D6
• •Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, neurologic, or renal functional abnormality, as determined by history, physical examination, and laboratory evaluation
• •History of hemolytic anemia
• •Any abnormal baseline laboratory screening tests listed below (normal values are defined by the current Quest Diagnostics reference guide on file in the CTC):
• •* ALT (alanine aminotransferase)above normal range
• •* Glomerular filtration rate (GFR) below normal range for the subject's ethnicity
• •* Hemoglobin below normal range
• •Hepatomegaly, right upper quadrant abdominal pain or tenderness
• •Suspected or known current alcohol abuse as determined from the medical history or by physical examination
• •Use of any drugs that may cause hemolytic anemia and/or bone marrow suppression such as quinacrine, dapsone, rifampin, colchicine, ribavirin, penicillamine and sulfonamides.
• •Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study