Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults

Part of paid clinical trials in East Syracuse, New York.

Sponsor
State University of New York - Upstate Medical University
Study ID
NCT07373743
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pharmacokinetic in Normal Population

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Tafenoquine Oral Tablet — DRUG
    Single, 300mg dose

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Normal Metabolizers (NM)
    Participants with normal CYP2D6 enzyme activity receiving a single 300 milligram (mg) dose of tafenoquine.
  • 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.
  • 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.
  • Experimental: Ultra Metabolizers (UM)
    Participants with increased enzyme activity, leading to accelerated metabolism, receiving 300mg dose of tafenoquine

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SUNY Upstate Medical University, Upstate Global Health InstituteEast SyracuseNew York13057
Keely Terrillion
[email protected]
315-464-9869
Michele Spring, MD (PRINCIPAL_INVESTIGATOR)

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By research site
SUNY Upstate Medical University, Upstate Global Health Institute· East Syracuse, NY