Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults
State University of New York - Upstate Medical University
Summary
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.
Description
This trial will explore the how different CYP450 2D6 phenotypes metabolize a single 300mg dose of tafenoquine. Pharmacokinetic (PK) blood and urine samples, and research samples will be obtained at specific timepoints during the 2-month study.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age 18-65 at the time of consent, weighing between 132 and 250 pounds 2. Ability and willingness to sign informed consent 3. Available for the study period 4. Willing to use contraception for the duration of the study 5. Agree not to take over the counter antioxidants, vitamin C or vitamin E, 2 weeks prior to dosing and 7 days post dosing Exclusion Criteria: 1. Women: positive urine pregnancy test at screening or day of dosing 2. Women who are lactating or intend to become pregnant during the study period. 3. Acute or chronic clinically significant hematologic, pulmon…
Interventions
- DrugTafenoquine Oral Tablet
Single, 300mg dose
Location
- SUNY Upstate Medical University, Upstate Global Health InstituteEast Syracuse, New York