Safety and Pharmacokinetics of Extrato De Cannabis Sativa GreenCare

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: Cannabis oil

• Registration Number: NCT06807762
• Lead Sponsor: GreenCare Pharma

Brief 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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-02-04
• Status Verified: 2025-03
• Study Start: 2025-03-18
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extrato de Cannabis sativa GreenCare 79.14 mg/mL	Cannabis oil	Concentration unit: 79.14 mg/mL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Frequency, intensity, and severity of adverse events	Up to 5 days
Plasma concentrations of CBD and THC	Up to 5 days

Trial Locations

Locations (1)

GreenCare Pharma; 🇧🇷 Vinhedo, Sao Paulo, Brazil