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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1 healthy

Timeline

Completed

Started Jul 2019

Longer than P75 for phase_1 healthy

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

Study Start

First participant enrolled

July 24, 2019

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed

Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

3.3 years

First QC Date

February 4, 2020

Last Update Submit

December 7, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

Pharmacokinetic analysis of Cmax
0-12 hours post dose
Pharmacokinetic analysis of Tlag
0-12 hours post dose
Pharmacokinetic analysis of Tmax
0-12 hours post dose
Pharmacokinetic analysis of AUC(0-t)
0-12 hours post dose
Pharmacokinetic analysis of AUC(0-∞)
0-12 hours post dose
Pharmacokinetic analysis of %AUC extrapolated
0-12 hours post dose
Pharmacokinetic analysis of T1/2
0-12 hours post dose
Pharmacokinetic analysis of clearance from plasma (Cl/F)
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 clearance from plasma dose normalized Cmax
0-12 hours post dose
Pharmacokinetic analysis of dose normalized AUC
0-12 hours post dose

Study Arms (4)

Single dose

EXPERIMENTAL

Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4

Drug: A1Drug: A2Drug: A3Drug: A4Drug: A5Drug: B1Drug: B2Drug: B3Drug: B4

Cross-Over food effect

EXPERIMENTAL

2 doses: fasted and fed state with the same product: A1, A4, A5, B4

Drug: A1Drug: A4Drug: A5Drug: B4

Cross-Over product comparison

EXPERIMENTAL

2 doses: in fasted state comparing A1 to A4

Drug: A1Drug: A4

Cross-over route of administration comparison

EXPERIMENTAL

2 doses: in fasted state comparing oral administration to sublingual administration of A4

Drug: A4

Interventions

A1DRUG

Medical Cannabis oil diluted in Olive oil. CBD 36.6 mg, THC 1.8 mg (6 drops)

Also known as: Celixir 20 T1/C20- CBD 20%, THC 1%

Cross-Over food effectCross-Over product comparisonSingle dose

A2DRUG

Medical Cannabis oil diluted in Olive oil. CBD 0.6 mg, THC 3.1 mg (1 drop)

Also known as: Telixir 10 T2/C10 - CBD 2%, THC 10%

Single dose

A3DRUG

Medical Cannabis oil diluted in Olive oil. CBD 3.1 mg. THC 3.1 mg (1 drop)

Also known as: Equatir 10 T10/C10 - CBD 10%, THC 10%

Single dose

A4DRUG

Medical Cannabis (oil diluted in MCT oil). CBD 34.8 mg, THC 1.7 mg (6 drops)

Also known as: C18T0.9 in MCT oil - CBD 18%, THC 0.9%

Cross-Over food effectCross-Over product comparisonCross-over route of administration comparisonSingle dose

A5DRUG

Medical Cannabis oil (diluted in MCT oil). CBD 0.6 mg, THC 3.1 mg (1 drop)

Also known as: T10/C2 - CBD 2%, THC 10%

Cross-Over food effectSingle dose

B1DRUG

Sublingual tablets. CBD 40 mg, THC 2 mg (1 tablet)

Also known as: Tablet: CBD 40 mg, THC 2 mg

Single dose

B2DRUG

Sublingual tablets. CBD 30 mg, THC 5 mg (1 tablet)

Also known as: Tablet: CBD 30 mg, THC 5 mg

Single dose

B3DRUG

Sublingual tablets. CBD 40 mg (1 tablet)

Also known as: Tablet: CBD 40 mg

Single dose

B4DRUG

Sublingual tablets. CBD 40 mg (1 tablet)

Also known as: Tablet: CBD 40 mg

Cross-Over food effectSingle dose

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy, male or female, between 18 and 45 years of age (inclusive).
Body mass index (BMI) between 20-30 kg/m2 (both inclusive)
No recent cannabis usage within 30 days from screening
Normal rage hepatic functions
No electrolytes abnormalities
Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges:
Body temperature between 35.0 to 37.5 °C
Systolic blood pressure, 90 to 150 mmHg\*
Diastolic blood pressure, 60 to 90 mmHg\*
Pulse rate, 50 to 90 beats per minute\*.
\*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).

You may not qualify if:

Blood donation within 90 days
History of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastroenterology, endocrine, immunology, dermatologic, neurologic or psychiatric disorders
Subjects with a history of alcohol, drug abuse, chronic cannabis use within 2 years of study
Pregnant women
Subjects who used any prescription or OTC medication in the past 14 days with the exception of paracetamol or ibuprofen.
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
Pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
Subjects who had postural drop of \> 20 mmHg in systolic blood pressure at screening
Patients with heart failure,
Subjects with a history of psychotic state in the past or anxiety disorder,
Subjects at age of less than 30 years with a history of psychiatric disease in a first-degree family member
Subjects with a history of addiction or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Breath of Life International Pharma Ltdlead

Study Sites (1)

Ziv Medical Center

Safed, 13100, Israel

Location

MeSH Terms

Interventions

DronabinolL 644711

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 7, 2020

Study Start

July 24, 2019

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing: Will not share

Locations

IL(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (11)

Study Arms (4)

Single dose

Cross-Over food effect

Cross-Over product comparison

Cross-over route of administration comparison

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Data Sharing

Locations