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Набор скоро начнётся NCT07373743

Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults

Ранняя фаза I С лечением Pharmacokinetic in Normal Population

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Tafenoquine Oral Tablet.
Кому может быть актуально
Состояния в реестре: Pharmacokinetic in Normal Population. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат Tafenoquine Oral Tablet
    Single, 300mg dose

Первичные конечные точки

  • Tafenoquine levels in blood over time [Срок оценки: 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 [Срок оценки: 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.]
Вторичные конечные точки (4)
  • Methemoglobin Levels [Срок оценки: 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 [Срок оценки: Pre-dose, Day 4 and 15]
  • Adverse Events [Срок оценки: From Day 1 to Day 29]
  • Serious Adverse Events [Срок оценки: Day 1 to Day 57]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.
  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • SUNY Upstate Medical University, Upstate Global Health Institute — East Syracuse

Идентификаторы

NCT: NCT07373743 · 2026-01-UMU · PR241374

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗