Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults

March 18, 2026 updated by: State University of New York - Upstate Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • East Syracuse, New York, United States, 13057
        • SUNY Upstate Medical University, Upstate Global Health Institute
        • Contact:
        • Principal Investigator:
          • Michele Spring, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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, pulmonary, cardiovascular, hepatic, or renal functional abnormality as determined by medical history, physical examination or laboratory screening.
  4. History of allergic reaction to tafenoquine or primaquine.
  5. 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.
  6. Currently taking metformin, dofeltilide or other medication with known multidrug and toxin extrusion enzyme (MATE) metabolism.
  7. Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy.
  8. 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.
  9. 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.
  10. Positive HIV, hepatitis B surface antigen or hepatitis C.
  11. G6PD result not normal or < 70% activity
  12. Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact participant safety, including BMI > 35kg/m2
  13. Participation (active or follow-up phase) or planned participation in another vaccine, or drug, in the 4 weeks prior to or during the trial
  14. Beliefs that bar the administration of blood products or transfusions
  15. Clinician discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Normal Metabolizers (NM)
Participants with normal CYP2D6 enzyme activity receiving a single 300 milligram (mg) dose of tafenoquine.
Drug: Tafenoquine Oral Tablet
Single, 300mg dose
Experimental: Intermediate Metabolizers (IM)
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 300mg dose of tafenoquine.
Drug: Tafenoquine Oral Tablet
Single, 300mg dose
Experimental: Poor Metabolizers (PM)
Participants with no enzyme activity at all, leading to a null phenotype and no drug metabolism, receiving a single 300mg dose of tafenoquine.
Drug: Tafenoquine Oral Tablet
Single, 300mg dose
Experimental: Ultra Metabolizers (UM)
Participants with increased enzyme activity, leading to accelerated metabolism, receiving 300mg dose of tafenoquine
Drug: Tafenoquine Oral Tablet
Single, 300mg dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Methemoglobin Levels at defined PK timepoints
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
Complete Blood Count and reticulocyte count
Pre-dose, Day 4 and 15
Adverse Events
Time Frame: From Day 1 to Day 29
From Day 1 to Day 29
Serious Adverse Events
Time Frame: Day 1 to Day 57
Day 1 to Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York - Upstate Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michele Spring, MD, State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-01-UMU
  • PR241374 (Other Grant/Funding Number: Congressionally Directed Medical Research Programs (CDMRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlies the primary results in a publication.

IPD Sharing Time Frame

IPD will be shared with the primary publication

IPD Sharing Access Criteria

Primary IPD will be published with the primary manuscript describing the study. Requests for additional information can be requested by emailing warel@upstate.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings