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

Breath of Life Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: A4; Drug: A2; Drug: B1; Drug: A1; Drug: A3; Drug: B4; Drug: B2; Drug: A5; Drug: B3

Study type: Interventional

Funder types: Industry

Identifiers

NCT04261166

BOL-PK-ST-02

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

Single dose

Experimental group

Description:

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

Treatment:

Drug: B3

Drug: A5

Drug: B2

Drug: B4

Drug: A3

Drug: A1

Drug: B1

Drug: A2

Drug: A4

Cross-Over food effect

Experimental group

Description:

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

Treatment:

Drug: A5

Drug: B4

Drug: A1

Drug: A4

Cross-Over product comparison

Experimental group

Description:

2 doses: in fasted state comparing A1 to A4

Treatment:

Drug: A1

Drug: A4

Cross-over route of administration comparison

Experimental group

Description:

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

Treatment:

Drug: A4