Clinical trial NCT06807762: Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: GreenCare Pharma
Sponsor class: INDUSTRY
First posted: 2025-02-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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?


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.

Primary outcomes:
measure: Identification of the Maximum Tolerated Dose (MTD) of Cannabis sativa Extract GreenCare 79,14 mg/mL
timeFrame: Up to 5 days
Secondary outcomes:
measure: Frequency, intensity, and severity of adverse events
timeFrame: Up to 5 days
measure: Plasma concentrations of CBD and THC
timeFrame: Up to 5 days
Other outcomes:
Locations:
city: Vinhedo
country: Brazil
facility: GreenCare Pharma
state: Sao Paulo
Study officials:
affiliation: Synvia Clinical | CAEP
name: Fernando Pacheco, MD
role: PRINCIPAL_INVESTIGATOR
References: