Clinical Trial on Pharmacokinetic and Tolerability of AP701

Safety Clinical Trial

Official title:

Clinical Trial on Pharmacokinetic and Tolerability of AP701

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708795
• Other study ID #: SELECT
• Status: Completed
• Phase: Phase 1
• Start date: January 11, 2020
• Est. completion date: March 7, 2021

Study information

• Verified date: March 2021
• Source: CannaXan GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 7, 2021
• Est. primary completion date: March 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pharmacokinetic
• Safety
• Tolerability

Intervention

Drug:
• AP701
Preparation of Cannabis flowers (Cannabis flos)

Locations

Country	Name	City	State
Germany	Phase I Unit of CannaXan GmbH	Warngau	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
CannaXan GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pharmacokinetic parameter of THC (area under the curve)	Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product	30 hours
Primary	Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration)	Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product	30 hours
Primary	Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration)	Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits)	Pharmacokinetic outcome of THC measured 0 to detection limits after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of THC (area under the curve from 0 to 24 hours)	Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product	24 hours
Secondary	Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits)	Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits)	Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope)	Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from timepoint zero to quantification limits)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from 0 to 24 hours)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product	24 hours
Secondary	Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of 11-OH-THC (time of last drug concentration above quantification limits)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product	30 hours
Secondary	Adverse events (AE)	Number and severity of adverse events (AE)	30 hours
Secondary	Pschotropic drug effects measured by questionnaire	Questionnaire comprising 17 questions on intoxication to be answered on numeric rating scale	30 hours