Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare
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
GreenCare Pharma
72 participants
Mar 18, 2025
INTERVENTIONAL
Conditions
Summary
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?
Eligibility
Inclusion Criteria5
- 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).
Exclusion Criteria15
- 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.
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Interventions
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=12) will receive the MTD determined in Stage 1, administered in two daily doses for 14 consecutive days.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06807762