Clinical Trial on Pharmacokinetic and Tolerability of AP701

• Sponsor: CannaXan GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04708795
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetic; Tolerability; Safety	Drug: AP701	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clinical Trial on Pharmacokinetic and Tolerability of AP701
• Actual Study Start Date: Jan 11, 2020
• Actual Primary Completion Date: Mar 7, 2021
• Actual Study Completion Date: Mar 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Verum AP701 single dose oromucosal application	Drug: AP701; Preparation of Cannabis flowers (Cannabis flos)

Outcome Measures

Primary Outcome Measures

1. Evaluation of pharmacokinetic parameter of THC (area under the curve) [30 hours]

   Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product

2. Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration) [30 hours]

   Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product

3. Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration) [30 hours]

   Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product

Secondary Outcome Measures

1. Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits) [30 hours]

   Pharmacokinetic outcome of THC measured 0 to detection limits after application of investigational product

2. Evaluation of pharmacokinetic parameter of THC (area under the curve from 0 to 24 hours) [24 hours]

   Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product

3. Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits) [30 hours]

   Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product

4. Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits) [30 hours]

   Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product

5. Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope) [30 hours]

   Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product

6. Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve) [30 hours]

   Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product

7. Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration) [30 hours]

   Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product

8. Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration) [30 hours]

   Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product

9. Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from timepoint zero to quantification limits) [30 hours]

   Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product

10. Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from 0 to 24 hours) [24 hours]

    Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product

11. Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits) [30 hours]

    Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product

12. Evaluation of pharmacokinetic parameter of 11-OH-THC (time of last drug concentration above quantification limits) [30 hours]

    Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product

13. Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope) [30 hours]

    Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product

14. Adverse events (AE) [30 hours]

    Number and severity of adverse events (AE)

15. Pschotropic drug effects measured by questionnaire [30 hours]

    Questionnaire comprising 17 questions on intoxication to be answered on numeric rating scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phase I Unit of CannaXan GmbH	Warngau	Bavaria	Germany	D-83627

Sponsors and Collaborators

• CannaXan GmbH

Investigators

• Principal Investigator: Stefan Lorenzl, PhD, Phase I Unit of CannaXan GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CannaXan GmbH
• ClinicalTrials.gov Identifier: NCT04708795
• Other Study ID Numbers: SELECT
• First Posted: Jan 14, 2021
• Last Update Posted: Mar 10, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by CannaXan GmbH: Cannabis; Cannabis based medicine; THC; Tetrahydrocannbinol

Study Results

No Results Posted as of Mar 10, 2021