Tafenoquine (ARAKODA) Pharmacokinetic Study in Healthy Adults

This study is looking for healthy adults aged 18-65 to understand how their bodies process the malaria prevention drug, Tafenoquine (ARAKODA). Researchers want to see how different genetic makeups affect how Tafenoquine is changed into its active form in the body. You would receive a single 300mg dose of Tafenoquine. The main goal is to measure the levels of Tafenoquine in your blood and urine over about two months to understand how your body handles the drug. This information helps us learn more about how Tafenoquine works in different people.

Study design
This is an interventional study planning to enroll 20 healthy adult participants. It will examine how different genetic types (CYP450 2D6 phenotypes) process Tafenoquine.
What's involved
You would take a single dose of Tafenoquine and have blood and urine samples collected at specific times over approximately two months. You would also need to use contraception and avoid certain over-the-counter antioxidants for a period.
Compensation
Not stated in the trial record.
Follow-up
Blood and urine levels of Tafenoquine will be measured for up to 57 days after the dose.

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NCT07373743

Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults

Not Yet Recruiting
EARLY_PHASE1Ages 18–65InterventionalBasic science
State University of New York - Upstate Medical University
~20 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Tafenoquine Oral Tablet

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tafenoquine levels in blood over time
Measured over Pre-dose, 4, 8, 12, and 24 hours (Day 2) and Days, 3, 4, 5, 6, 7, 8, 15, 22, 29, and 57.
+1 more outcome measured
Pharmacokinetic in Normal Population
1 sites across 1 states
New York1
  • Michele Spring, MD · PRINCIPAL_INVESTIGATOR · State University of New York - Upstate Medical University

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  • Tafenoquine levels in blood over timePre-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 timePre-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.