Clinical Trial on Pharmacokinetic and Tolerability of AP701

Phase 1

Completed

• Conditions: Tolerability; Pharmacokinetic; Safety
• Interventions: Drug: AP701

• Registration Number: NCT04708795
• Lead Sponsor: CannaXan GmbH

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.

Study Timeline

• Study Start: 2020-01-11
• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Status Verified: 2021-03
• Primary Completion: 2021-03-07
• Study Completion: 2021-03-07
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Verum	AP701	AP701 single dose oromucosal application

Primary Outcome Measures

Name	Time	Method
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
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
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

Name	Time	Method
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
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
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
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
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
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
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
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
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
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
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
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
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
Adverse events (AE)	30 hours	Number and severity of adverse events (AE)
Pschotropic drug effects measured by questionnaire	30 hours	Questionnaire comprising 17 questions on intoxication to be answered on numeric rating scale

Trial Locations

Locations (1)

Phase I Unit of CannaXan GmbH; 🇩🇪 Warngau, Bavaria, Germany