About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-65 at the time of consent, weighing between 132 and 250 pounds
Ability and willingness to sign informed consent
Available for the study period
Willing to use contraception for the duration of the study
Disqualifiers
Women: positive urine pregnancy test at screening or day of dosing
Women who are lactating or intend to become pregnant during the study period.
Acute or chronic clinically significant hematologic, pulmonary, cardiovascular, hepatic, or renal functional abnormality as determined by medical history, physical examination or laboratory screening.
History of allergic reaction to tafenoquine or primaquine.
Trial design
Parallel
Treatments tested in this trial
Tafenoquine Oral Tablet
DrugSingle, 300mg dose
Treatment groups
Trial outcomes
Primary outcomes
Tafenoquine levels in blood over time
Tafenoquine levels in urine over time
Secondary outcomes
Methemoglobin Levels
Methemoglobin Levels at defined PK timepoints
Laboratory abnormalities
Complete Blood Count and reticulocyte count
Adverse Events
Serious Adverse Events
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: