The goal of this clinical trial is to learn how people's different genetic makeups affects how their bodies convert the FDA approved drug ARAKODA (tafenoquine) to its active form. Tafenoquine is a drug that is taken to prevent malaria for people traveling to areas where there is malaria. This trial will be in healthy participants age 18-65.
This trial will explore the how different CYP450 2D6 phenotypes metabolize a single 450mg dose of tafenoquine. Pharmacokinetic (PK) blood and urine samples, and research samples will be obtained at specific timepoints during the 2-month study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Single, 450mg dose
SUNY Upstate Medical University, Upstate Global Health Institute
East Syracuse, New York, United States
Tafenoquine levels in blood over time
Time frame: Pre-dose, 4, 8, 12, and 24 hours (Day 2) and Days, 3, 4, 5, 6, 7, 8, 15, 22, 29, and 57.
Tafenoquine levels in urine over time
Time frame: Pre-dose, total volume collected between 0-4, 4-8, 8-12, 12-24 hours and then single void collections on Days 3, 4, 5, 6, 7, 8, 15, 22, 29, 57.
Methemoglobin Levels
Methemoglobin Levels at defined PK timepoints
Time frame: Pre-dose, 4, 8, 12, and 24 hours (Day 2) and Days, 3, 4, 5, 6, 7, 8, 15, 22, 29, and 57
Laboratory abnormalities
Complete Blood Count and reticulocyte count
Time frame: Pre-dose, Day 4 and 15
Adverse Events
Time frame: From Day 1 to Day 29
Serious Adverse Events
Time frame: Day 1 to Day 57
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