Clinical Trial on Pharmacokinetic and Tolerability of AP701

NCT ID: NCT04708795

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-11
• Study Completion Date: 2021-03-07

Brief Summary

This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

Detailed Description

Pharmacokinetic parameters and tolerability of AP701 is studied over 30 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.

Conditions

Pharmacokinetic; Tolerability; Safety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Verum

AP701 single dose oromucosal application

Group Type: EXPERIMENTAL

AP701

Intervention Type: DRUG

Preparation of Cannabis flowers (Cannabis flos)

Interventions

AP701

Preparation of Cannabis flowers (Cannabis flos)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed and dated informed consent form

2. Male in the age of 35 - 60 year at study start

3. Body mass index of 18 to 30 kg/m2

4. Non-smoker, no use of any Tabaco products

5. Good general health status (Karnofsky Score = 100)

6. Current ECG without abnormal findings (i.a. QTcF < 450 ms)

7. Physical examination, medical history without exclusionary findings

8. Pulse rate between 50 and 90 bpm

9. Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg

10. Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges

11. Lab values for renal function (S-Creatinine, eGFR) within normal range

12. Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody

13. Negative test result of urine screening for Cannabis, alcohol, and substance abuse

Exclusion Criteria

1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure

2. Use of Cannabis products within the last 8 weeks

3. Use of opioids

4. Former or present dependency (e.g. to alcohol, medicinal products, drugs)

5. Participation in another clinical trial within the last four weeks prior to study inclusion

6. Present, former, or family history of mental illnesses such as severe de pression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder

7. Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)

8. Body temperature ≥ 38 °C

9. Present cardiovascular, respiratory, diabetic, or cancer disease

10. Hepatitis or other liver and renal disease

11. Other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial

12. Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)

13. Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

CannaXan GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Lorenzl, PhD

Role: PRINCIPAL_INVESTIGATOR

Phase I Unit of CannaXan GmbH

Locations

Phase I Unit of CannaXan GmbH

Warngau, Bavaria, Germany

Countries

Germany

Other Identifiers

SELECT

Identifier Type: -

Identifier Source: org_study_id