Clinical trial NCT04261166: A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Breath of Life International Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2020-02-07
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetic analysis of Cmax
timeFrame: 0-12 hours post dose
measure: Pharmacokinetic analysis of Tlag
timeFrame: 0-12 hours post dose
measure: Pharmacokinetic analysis of Tmax
timeFrame: 0-12 hours post dose
measure: Pharmacokinetic analysis of AUC(0-t)
timeFrame: 0-12 hours post dose
measure: Pharmacokinetic analysis of AUC(0-∞)
timeFrame: 0-12 hours post dose
measure: Pharmacokinetic analysis of %AUC extrapolated
timeFrame: 0-12 hours post dose
measure: Pharmacokinetic analysis of T1/2
timeFrame: 0-12 hours post dose
measure: Pharmacokinetic analysis of clearance from plasma (Cl/F)
timeFrame: 0-12 hours post dose
measure: Pharmacokinetic analysis of ratio of the Volume of distribution based on the terminal phase to the bioavailability (Vz/F)
timeFrame: 0-12 hours post dose
measure: Pharmacokinetic analysis of clearance from plasma dose normalized Cmax
timeFrame: 0-12 hours post dose
measure: Pharmacokinetic analysis of dose normalized AUC
timeFrame: 0-12 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Zefat
country: Israel
facility: Ziv Medical Center
Study officials:
References: