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Идёт набор NCT06807762

Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare

Фаза I С лечением Healthy

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: Cannabis oil.
Кому может быть актуально
Состояния в реестре: Healthy. 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
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Phase I Clinical Trial to Assess Tolerability, Safety, and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare 79.14 mg/mL - Drops Solution - in Healthy Research Participants of Both Sexes in a Fed State

Обзор

The goal of this Phase I clinical trial is to assess the pharmacokinetic availability and safety and tolerability profile of Extrato de Cannabis sativa GreenCare 79.14 mg/mL. The main question it aims to answer is: • Is the Extrato de Cannabis sativa GreenCare 79,14 mg/mL safe?

Вмешательства

  • Препарат Cannabis oil
    Healthy subjects will be treated with a solution of Cannabis sativa extract diluted in MCT oil, at doses ranging from 39.62 mg to 791.4 mg. This protocol will be divided into two stages: Stage 1 - Determination of the Maximum Tolerated Dose (MTD): Participants (n=60) will be dynamically randomized and will receive Cannabis sativa extract (GreenCare, 79.14 mg/mL) as a single dose after breakfast, with doses ranging from 39.62 mg to 791.4 mg. Stage 2 - Assessment of the MTD: All participants (n=

Первичные конечные точки

  • Identification of the Maximum Tolerated Dose (MTD) of Cannabis sativa Extract GreenCare 79,14 mg/mL [Срок оценки: Up to 5 days]
Вторичные конечные точки (2)
  • Frequency, intensity, and severity of adverse events [Срок оценки: Up to 5 days]
  • Plasma concentrations of CBD and THC [Срок оценки: Up to 5 days]

Критерии участия

Критерии включения

  • Men and women from 18 to 65 years, inclusive;
  • Body weight ≥ 50 kg and BMI between 18.5 and 30 kg/m2, inclusive;
  • Be healthy according to medical history, i.e., have laboratory test results within normal ranges and/or any deviations from normal classified as clinically insignificant;
  • Be exclusively participating in this clinical study during the research period;
  • Understand and comply with the protocol requirements and consent to participate in the study by signing the Informed Consent Form (ICF) approved by an Ethics Committee (EC).

Критерии исключения

Having participated in any experimental study or ingested any experimental drug within 1 (one) year prior to the start of this study;

  • Inability to use oral medication and/or cooperate with investigators due to cognitive impairment or mental state;
  • Reported allergy to any component of Cannabis sativa extract 79.14 mg/mL;
  • Personal or first-degree family history of schizophrenia, bipolar affective disorder, psychotic symptoms, suicidal ideation, planning and/or attempt, and/or severe uncontrolled psychiatric comorbidities, at the discretion of the principal investigator;
  • Donated blood within four (4) months prior to signing the Informed Consent Form (ICF);
  • Being pregnant, breastfeeding, intending to become pregnant during the study period, or having a positive result for urinary β-HCG testing;
  • Reported use of Cannabis and/or its derivatives for any purpose in the past 6 months;
  • Personal history of Cannabis use disorder and/or other illicit drug use disorder;
  • Personal history of alcohol, tobacco, opioid, benzodiazepine, barbiturate, and/or other substance use disorders, such as St. John's Wort;
  • Smokers or ex-smokers who quit less than 6 months ago;
  • Consumed alcoholic beverages within 24 hours before the study confinement period;
  • Any condition that prevents participation at the discretion of the investigator;
  • Dietary habits that prevent ingestion of the diet provided during the study;
  • Any clinical or laboratory finding or therapy that, at the investigator's discretion, may place the participant at risk or interfere with study objectives or outcomes;
  • Non-compliance with the complete ingestion of the diet provided - determination at the discretion of the responsible physician.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • GreenCare Pharma — Vinhedo

Идентификаторы

NCT: NCT06807762 · GreenCare-ExtratoCannabis-0124 · 131.001.23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗