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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: A1; Drug: A4; Drug: A2; Drug: A3; Drug: A5; Drug: B1; Drug: B2; Drug: B3; Drug: B4

• Registration Number: NCT04261166
• Lead Sponsor: Breath of Life International Pharma Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-24
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Primary Completion: 2022-10-24
• Study Completion: 2022-10-24
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single dose	A1	Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4
Cross-Over product comparison	A4	2 doses: in fasted state comparing A1 to A4
Cross-over route of administration comparison	A4	2 doses: in fasted state comparing oral administration to sublingual administration of A4
Single dose	A2	Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4
Single dose	B4	Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4
Cross-Over food effect	A4	2 doses: fasted and fed state with the same product: A1, A4, A5, B4
Single dose	A4	Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4
Single dose	B1	Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4
Single dose	B2	Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4
Single dose	B3	Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4
Cross-Over food effect	A1	2 doses: fasted and fed state with the same product: A1, A4, A5, B4
Cross-Over product comparison	A1	2 doses: in fasted state comparing A1 to A4
Single dose	A3	Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4
Cross-Over food effect	B4	2 doses: fasted and fed state with the same product: A1, A4, A5, B4
Single dose	A5	Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4
Cross-Over food effect	A5	2 doses: fasted and fed state with the same product: A1, A4, A5, B4

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic analysis of %AUC extrapolated	0-12 hours post dose
Pharmacokinetic analysis of clearance from plasma dose normalized Cmax	0-12 hours post dose
Pharmacokinetic analysis of T1/2	0-12 hours post dose
Pharmacokinetic analysis of Tlag	0-12 hours post dose
Pharmacokinetic analysis of AUC(0-t)	0-12 hours post dose
Pharmacokinetic analysis of ratio of the Volume of distribution based on the terminal phase to the bioavailability (Vz/F)	0-12 hours post dose
Pharmacokinetic analysis of dose normalized AUC	0-12 hours post dose
Pharmacokinetic analysis of Tmax	0-12 hours post dose
Pharmacokinetic analysis of AUC(0-∞)	0-12 hours post dose
Pharmacokinetic analysis of clearance from plasma (Cl/F)	0-12 hours post dose
Pharmacokinetic analysis of Cmax	0-12 hours post dose

Trial Locations

Locations (1)

Ziv Medical Center; 🇮🇱 Zefat, Israel