Clinical Trial on Pharmacokinetics and Tolerability of AP707

Brief Summary:This study aims to investigate the uptake of AP707, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Tolerability; Safety
• Intervention / Treatment: Drug: AP707

Detailed Description

Pharmacokinetic parameters and tolerability of AP707 is studied over 24 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Warngau, Bavaria, Germany, 83627
      • Phase I Unit of CannaXan GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Signed and dated informed consent form
2. Male at the age of 30 - 60 years at study start
3. Body mass index of 18 to 30 kg/m2
4. Non-smoker, no use of any tobacco products,
5. Good general health status (Karnofsky Score = 100; see Annex 1, page 59)
6. Current ECG without abnormal findings (no significant alterations from normal values, especially with regard to the QT interval (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 value for renal function (S-Creatinine, eGFR according to CKD-EPI) 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 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. Former or present mental illnesses such as severe depression, 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 A, B, C 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Verum; AP707 single dose oromucosal application	Drug: AP707; Preparation of Cannabis flowers (Cannabis flos); Other Names: THC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pharmacokinetic parameter of THC (area under the curve)	Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product	24 hours
Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration)	Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product	24 hours
Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration)	Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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	24 hours
Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits)	Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product	24 hours
Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits)	Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product	24 hours
Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope)	Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product	24 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product	24 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product	24 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product	24 hours
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 24 hours after application of investigational product	24 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product	24 hours
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 24 hours after application of investigational product	24 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope)	Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product	24 hours
Adverse events (AE)	Number and severity of adverse events (AE)	24 hours
Psychotropic drug effects measured by questionnaire	Questionnaire comprising 17 questions on intoxication to be answered on numeric rating scale (on a scale from 0 to 10, where 0 means "not at all" (no agreement) and 10 means "extremely" (strongest agreement).	24 hours

Collaborators and Investigators

• Sponsor: CannaXan GmbH
• Investigators: Principal Investigator: Stefan Lorenzl, Prof. Dr., Phase I Unit of CannaXan GmbH

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2022
• Primary Completion (ACTUAL): April 3, 2022
• Study Completion (ACTUAL): April 3, 2022

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (ACTUAL): March 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cannabis; THC; Tetrahydrocannabinol; Cannabis based medicine
• Other Study ID Numbers: SELECT 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No