Pharmacokinetic in Normal PopulationEarly Phase 1NCT07373743
Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults
A Early Phase 1 study testing Tafenoquine Oral Tablet in people with Pharmacokinetic in Normal Population, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic in Normal Population
- What is being tested?
- Tafenoquine Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
SUNY Upstate Medical University, Upstate Global Health Institute
East Syracuse, New York, 13057
Keely Terrillion, 315-464-9869, trials@upstate.edu
Michele Spring, MD
About this study
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.
Read the 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
- Being tested
- Tafenoquine Oral Tablet
- Keywords
- Tafenoquine, CYP2D6, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafenoquine Oral TabletDrug
Single, 300mg dose
| Study group | Role | What they receive |
|---|---|---|
| Normal Metabolizers (NM) | Experimental | Participants with normal CYP2D6 enzyme activity receiving a single 300 milligram (mg) dose of tafenoquine. Receives: Drug: Tafenoquine Oral Tablet |
| Intermediate Metabolizers (IM) | Experimental | 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. Receives: Drug: Tafenoquine Oral Tablet |
| Poor Metabolizers (PM) | Experimental | Participants with no enzyme activity at all, leading to a null phenotype and no drug metabolism, receiving a single 300mg dose of tafenoquine. Receives: Drug: Tafenoquine Oral Tablet |
| Ultra Metabolizers (UM) | Experimental | Participants with increased enzyme activity, leading to accelerated metabolism, receiving 300mg dose of tafenoquine Receives: Drug: Tafenoquine Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tafenoquine levels in blood over time
Measured: 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
Measured: 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 outcomes (4)
Methemoglobin Levels
Methemoglobin Levels at defined PK timepoints
Measured: 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
Complete Blood Count and reticulocyte count
Measured: Pre-dose, Day 4 and 15
Adverse Events
Measured: From Day 1 to Day 29
Serious Adverse Events
Measured: Day 1 to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic in Normal PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Spring, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373743
- Sponsor's protocol ID
- 2026-01-UMU
- Other IDs
- PR241374
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlies the primary results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults
- ClinicalTrials.gov ID
- NCT07373743
- Acronym / sponsor ID
- 2026-01-UMU
- Conditions
- Pharmacokinetic in Normal Population
- Keywords
- Tafenoquine, CYP2D6, Pharmacokinetic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Metabolizers (NM) | Experimental | Drug: Tafenoquine Oral TabletParticipants with normal CYP2D6 enzyme activity receiving a single 300 milligram (mg) dose of tafenoquine. |
| Intermediate Metabolizers (IM) | Experimental | Drug: Tafenoquine Oral TabletParticipants 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. |
| Poor Metabolizers (PM) | Experimental | Drug: Tafenoquine Oral TabletParticipants with no enzyme activity at all, leading to a null phenotype and no drug metabolism, receiving a single 300mg dose of tafenoquine. |
| Ultra Metabolizers (UM) | Experimental | Drug: Tafenoquine Oral TabletParticipants with increased enzyme activity, leading to accelerated metabolism, receiving 300mg dose of tafenoquine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tafenoquine Oral TabletSingle, 300mg dose | Drug | Intermediate Metabolizers (IM), Normal Metabolizers (NM), Poor Metabolizers (PM), Ultra Metabolizers (UM) |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlies the primary results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michele Spring, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tafenoquine Oral Tablet in people with Pharmacokinetic in Normal Population, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keely Terrillion (315-464-9869, trials@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.