Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare

NCT06807762 | Recruiting Phase 1 DMC

• 2 other identifiers: GreenCare-ExtratoCannabis-0124131.001.23
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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?

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Identification of the Maximum Tolerated Dose (MTD) of Cannabis sativa Extract GreenCare 79,14 mg/mL

  Up to 5 days

Secondary Outcomes (2)

• Frequency, intensity, and severity of adverse events

  Up to 5 days

• Plasma concentrations of CBD and THC

  Up to 5 days

Study Arms (1)

Extrato de Cannabis sativa GreenCare 79.14 mg/mL

EXPERIMENTAL

Concentration unit: 79.14 mg/mL

Drug: Cannabis oil

Interventions

Cannabis oil DRUG

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.

Also known as: Extrato de Cannabis sativa GreenCare 79.14 mg/mL

Extrato de Cannabis sativa GreenCare 79.14 mg/mL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GreenCare Pharma: lead

Study Sites (1)

GreenCare Pharma

Vinhedo, São Paulo, 13288006, Brazil

RECRUITING

MeSH Terms

Interventions

nabiximols

Study Officials

• Fernando Pacheco, MD

  Synvia Clinical | CAEP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Furtado

CONTACT

+5511942562895; fabio.furtado@greencarepharma.com.br

Helena Joaquim, MsC, PhD

CONTACT

+5511942562895; helena.joaquim@greencarepharma.com.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 4, 2025
• Study Start: March 18, 2025
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

BR (1)