A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract

Healthy Clinical Trial

Official title:

A Phase I Open Label Study to Assess the Single Dose Pharmacokinetics and Safety of Sublingual Administration of Tablets and Medicated Drops of Plant Cannabis Extract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261166
• Other study ID #: BOL-PK-ST-02
• Status: Completed
• Phase: Phase 1
• Start date: July 24, 2019
• Est. completion date: October 24, 2022

Study information

• Verified date: December 2022
• Source: Breath of Life International Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy, male or female, between 18 and 45 years of age (inclusive).

2. Body mass index (BMI) between 20-30 kg/m2 (both inclusive)

3. No recent cannabis usage within 30 days from screening

4. Normal rage hepatic functions

5. No electrolytes abnormalities

6. Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges:

1. Body temperature between 35.0 to 37.5 °C

2. Systolic blood pressure, 90 to 150 mmHg*

3. Diastolic blood pressure, 60 to 90 mmHg*

4. Pulse rate, 50 to 90 beats per minute*.

5. *Blood pressure and pulse rate will be taken again in a standing position. After two minutes standing, there shall be no more than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure, associated with clinical manifestation of postural hypotension).

Exclusion Criteria:

1. Blood donation within 90 days

2. History of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastroenterology, endocrine, immunology, dermatologic, neurologic or psychiatric disorders

3. Subjects with a history of alcohol, drug abuse, chronic cannabis use within 2 years of study

4. Pregnant women

5. Subjects who used any prescription or OTC medication in the past 14 days with the exception of paracetamol or ibuprofen.

6. Sexually active males whose partner is of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP. Sexually active females of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP

7. Pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.

8. Subjects who had postural drop of > 20 mmHg in systolic blood pressure at screening

9. Patients with heart failure,

10. Subjects with a history of psychotic state in the past or anxiety disorder,

11. Subjects at age of less than 30 years with a history of psychiatric disease in a first-degree family member

12. Subjects with a history of addiction or drug abuse

Related Conditions & MeSH terms

• Healthy
• Marijuana Abuse

Intervention

Drug:
• A1
Medical Cannabis oil diluted in Olive oil. CBD 36.6 mg, THC 1.8 mg (6 drops)
• A2
Medical Cannabis oil diluted in Olive oil. CBD 0.6 mg, THC 3.1 mg (1 drop)
• A3
Medical Cannabis oil diluted in Olive oil. CBD 3.1 mg. THC 3.1 mg (1 drop)
• A4
Medical Cannabis (oil diluted in MCT oil). CBD 34.8 mg, THC 1.7 mg (6 drops)
• A5
Medical Cannabis oil (diluted in MCT oil). CBD 0.6 mg, THC 3.1 mg (1 drop)
• B1
Sublingual tablets. CBD 40 mg, THC 2 mg (1 tablet)
• B2
Sublingual tablets. CBD 30 mg, THC 5 mg (1 tablet)
• B3
Sublingual tablets. CBD 40 mg (1 tablet)
• B4
Sublingual tablets. CBD 40 mg (1 tablet)

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Zefat

Sponsors (1)

Lead Sponsor	Collaborator
Breath of Life International Pharma Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic analysis of Cmax		0-12 hours post dose
Primary	Pharmacokinetic analysis of Tlag		0-12 hours post dose
Primary	Pharmacokinetic analysis of Tmax		0-12 hours post dose
Primary	Pharmacokinetic analysis of AUC(0-t)		0-12 hours post dose
Primary	Pharmacokinetic analysis of AUC(0-8)		0-12 hours post dose
Primary	Pharmacokinetic analysis of %AUC extrapolated		0-12 hours post dose
Primary	Pharmacokinetic analysis of T1/2		0-12 hours post dose
Primary	Pharmacokinetic analysis of clearance from plasma (Cl/F)		0-12 hours post dose
Primary	Pharmacokinetic analysis of ratio of the Volume of distribution based on the terminal phase to the bioavailability (Vz/F)		0-12 hours post dose
Primary	Pharmacokinetic analysis of clearance from plasma dose normalized Cmax		0-12 hours post dose
Primary	Pharmacokinetic analysis of dose normalized AUC		0-12 hours post dose