NCT07373743

Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pharmacokinetic in Normal Population

Interventions

Type	Name	Description
DRUG	Tafenoquine Oral Tablet	Single, 300mg dose

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-01-28
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study