Assessing the safety and pharmacokinetics of cannabis extract

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

This study is testing whether a cannabis oil is safe for healthy adults aged 18 to 65 to use.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: GreenCare Pharma (Industry-sponsored)
• Locations: 1 site (Vinhedo, São Paulo)
• Trial ID: NCT06807762 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial evaluates the safety, tolerability, and pharmacokinetic profile of Extrato de Cannabis sativa GreenCare at a concentration of 79.14 mg/mL. The study involves healthy adult participants aged 18 to 65, who will receive the cannabis oil and undergo monitoring for any adverse effects. The primary objective is to determine whether this cannabis extract is safe for human use. Participants will be required to meet specific health criteria and will be closely observed throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy men and women aged 18 to 65 with a body weight of at least 50 kg and a BMI between 18.5 and 30.

Not a fit: Patients with a history of schizophrenia, bipolar disorder, or allergies to cannabis extract may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety profile of cannabis extracts, potentially paving the way for future therapeutic applications.

How similar studies have performed: While there have been studies on cannabis extracts, this specific approach focusing on the safety and pharmacokinetics of this particular formulation is relatively novel.

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.

Where this trial is running

Vinhedo, São Paulo

• GreenCare Pharma — Vinhedo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Fernando Pacheco, MD — Synvia Clinical | CAEP
• Study coordinator: Fabio Furtado

Conditions Healthy