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Recruiting NCT06807762

Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cannabis oil.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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?

Interventions

  • Drug 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=

Primary outcome measures

  • Identification of the Maximum Tolerated Dose (MTD) of Cannabis sativa Extract GreenCare 79,14 mg/mL [Time frame: Up to 5 days]
Secondary outcome measures (2)
  • Frequency, intensity, and severity of adverse events [Time frame: Up to 5 days]
  • Plasma concentrations of CBD and THC [Time frame: Up to 5 days]

Eligibility criteria

Inclusion criteria

  • 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 criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • GreenCare Pharma — Vinhedo

Identifiers

NCT: NCT06807762 · GreenCare-ExtratoCannabis-0124 · 131.001.23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗