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Not yet recruiting NCT07373743

Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults

Early Phase I Interventional Pharmacokinetic in Normal Population

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tafenoquine Oral Tablet.
Who it may be relevant to
Registry conditions: Pharmacokinetic in Normal Population. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Tafenoquine Oral Tablet
    Single, 300mg dose

Primary outcome measures

  • 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.]
Secondary outcome measures (4)
  • Methemoglobin Levels [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 [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]

Eligibility criteria

Inclusion criteria

  • 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
  • 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

  • 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.
  • Scheduled receipt of any vaccine 1 week prior to or after 4 weeks tafenoquine dosing. Routine COVID and influenza vaccination will be allowed outside of this timeframe.
  • Currently taking metformin, dofeltilide or other medication with known multidrug and toxin extrusion enzyme (MATE) metabolism.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy.
  • Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the participant from participating in the study.
  • Participants with hemoglobin, Creatinine, BUN, and Albumin of grade 2 or greater. Participants with eGFR <90mL/min/1.73m2; ALT >1.5x ULN, or AST >1.5x ULN. Any exclusionary lab abnormality may be repeated once. If a repeat screening blood test is performed, only the result of the second test will be reviewed and used to determine eligibility.
  • Positive HIV, hepatitis B surface antigen or hepatitis C.
  • G6PD result not normal or < 70% activity
  • Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact participant safety, including BMI > 35kg/m2
  • Participation (active or follow-up phase) or planned participation in another vaccine, or drug, in the 4 weeks prior to or during the trial
  • Beliefs that bar the administration of blood products or transfusions
  • Clinician discretion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • SUNY Upstate Medical University, Upstate Global Health Institute — East Syracuse

Identifiers

NCT: NCT07373743 · 2026-01-UMU · PR241374

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗