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Completed

NCT Number: NCT04261166

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ziv Medical Center

Safed, 13100, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

A1

Drug

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

Other names: Celixir 20 T1/C20- CBD 20%, THC 1%

A2

Drug

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

Other names: Telixir 10 T2/C10 - CBD 2%, THC 10%

A3

Drug

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

Other names: Equatir 10 T10/C10 - CBD 10%, THC 10%

A4

Drug

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

Other names: C18T0.9 in MCT oil - CBD 18%, THC 0.9%

A5

Drug

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

Other names: T10/C2 - CBD 2%, THC 10%

B1

Drug

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

Other names: Tablet: CBD 40 mg, THC 2 mg

B2

Drug

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

Other names: Tablet: CBD 30 mg, THC 5 mg

B3

Drug

Sublingual tablets. CBD 40 mg (1 tablet)

Other names: Tablet: CBD 40 mg

B4

Drug

Sublingual tablets. CBD 40 mg (1 tablet)

Other names: Tablet: CBD 40 mg

Primary outcomes

  1. Pharmacokinetic analysis of Cmax

    Time frame: 0-12 hours post dose

  2. Pharmacokinetic analysis of Tlag

    Time frame: 0-12 hours post dose

  3. Pharmacokinetic analysis of Tmax

    Time frame: 0-12 hours post dose

  4. Pharmacokinetic analysis of AUC(0-t)

    Time frame: 0-12 hours post dose

  5. Pharmacokinetic analysis of AUC(0-∞)

    Time frame: 0-12 hours post dose

  6. Pharmacokinetic analysis of %AUC extrapolated

    Time frame: 0-12 hours post dose

  7. Pharmacokinetic analysis of T1/2

    Time frame: 0-12 hours post dose

  8. Pharmacokinetic analysis of clearance from plasma (Cl/F)

    Time frame: 0-12 hours post dose

  9. Pharmacokinetic analysis of ratio of the Volume of distribution based on the terminal phase to the bioavailability (Vz/F)

    Time frame: 0-12 hours post dose

  10. Pharmacokinetic analysis of clearance from plasma dose normalized Cmax

    Time frame: 0-12 hours post dose

  11. Pharmacokinetic analysis of dose normalized AUC

    Time frame: 0-12 hours post dose

Sponsors and collaborators

Lead sponsor

Breath of Life International Pharma Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2020
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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