Tafenoquine Pharmacokinetics Study

Overseen By Keely Terrillion

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: State University of New York - Upstate Medical University

Must not be taking: Metformin, Dofetilide, MATE metabolism

Disqualifiers: Pregnancy, Lactation, Immunodeficiency, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Michele Spring, MD

Principal Investigator

State University of New York - Upstate Medical University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65, weighing between 132 and 250 pounds. Participants must be able to consent, available for the study period, agree to use contraception during the study, and avoid certain over-the-counter antioxidants around dosing time.

Inclusion Criteria

I am between 18 and 65 years old and weigh between 132 and 250 pounds.

I am willing and able to sign the informed consent.

I am available for the entire study period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 450mg dose of tafenoquine and undergo pharmacokinetic sampling

2 months

Multiple visits for PK sampling at specific timepoints

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tafenoquine

Trial Overview

The trial studies how different genetic makeups affect the body's processing of Tafenoquine Oral Tablet (ARAKODA), an FDA-approved drug used to prevent malaria in travelers going to areas with malaria risk.

How Is the Trial Designed?

Group I: Poor Metabolizers (PM) Experimental Treatment 1 Intervention

Participants with no enzyme activity at all, leading to a null phenotype and no drug metabolism receiving a single 450mg dose of tafenoquine.

Group II: Normal Metabolizers (NM) Experimental Treatment 1 Intervention

Participants with normal CYP2D6 enzyme activity receiving a single 450 milligram (mg) dose of tafenoquine.

Group III: Intermediate Metabolizers (IM) Experimental Treatment 1 Intervention

Participants with decreased activity of the enzyme leading to variable effects i.e., either no effect, increased adverse effects from TQ or reduced efficacy of the drug in endemic areas due to inadequate metabolism receiving a single 450mg dose of tafenoquine.

Who Is Running the Clinical Trial?

State University of New York - Upstate Medical University

Lead Sponsor

Trials

176

Recruited

27,600+