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

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?

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Cannabis oil

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fabio Furtado; Phone Number: +5511942562895; Email: fabio.furtado@greencarepharma.com.br
• Study Contact Backup: Name: Helena Joaquim, MsC, PhD; Phone Number: +5511942562895; Email: helena.joaquim@greencarepharma.com.br

Study Locations

• Brazil
  • Sao Paulo
    • Vinhedo, Sao Paulo, Brazil, 13288006
      • Recruiting
      • GreenCare Pharma
      • Contact: Study coordinator, MsC PhD; Phone Number: +55 11 942562895; Email: medical@greencarepharma.com.br
      • Contact: Fernando Pacheco, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Extrato de Cannabis sativa GreenCare 79.14 mg/mL; Concentration unit: 79.14 mg/mL

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=12) will receive the MTD determined in Stage 1, administered in two daily doses for 14 consecutive days.; Other Names: Extrato de Cannabis sativa GreenCare 79.14 mg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Identification of the Maximum Tolerated Dose (MTD) of Cannabis sativa Extract GreenCare 79,14 mg/mL	Up to 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency, intensity, and severity of adverse events	Up to 5 days
Plasma concentrations of CBD and THC	Up to 5 days

Collaborators and Investigators

• Sponsor: GreenCare Pharma
• Investigators: Principal Investigator: Fernando Pacheco, MD, Synvia Clinical | CAEP

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: GreenCare-ExtratoCannabis-0124; 131.001.23 (Other Identifier: Synvia Clinical | CAEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No