Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorState University of New York - Upstate Medical University

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tafenoquine Oral Tablet

    Drug

    Single, 300mg dose

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: Normal Metabolizers (NM)Experimental treatment 1 intervention
Group B: Intermediate Metabolizers (IM)Experimental treatment 1 intervention
Group C: Poor Metabolizers (PM)Experimental treatment 1 intervention
Group D: Ultra Metabolizers (UM)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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 outcomes

1

Methemoglobin Levels

Methemoglobin Levels at defined PK timepoints

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
2

Laboratory abnormalities

Complete Blood Count and reticulocyte count

Time frame
Pre-dose, Day 4 and 15
3

Adverse Events

Time frame
From Day 1 to Day 29
4

Serious Adverse Events

Time frame
Day 1 to Day 57

Other outcomes

Sponsors and contacts

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