Clinical Trial on Pharmacokinetics and Tolerability of AP707

CannaXan GmbH12 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pharmacokinetics Tolerability Safety

Interventions

AP707DRUG

Preparation of Cannabis flowers (Cannabis flos)

Eligibility

Sex: MALEMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Phase I Unit of CannaXan GmbH

Warngau, Bavaria, Germany

Outcomes

Primary Outcomes

Evaluation of pharmacokinetic parameter of THC (area under the curve)

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

Time frame: 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

Time frame: 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

Time frame: 24 hours

Secondary Outcomes

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

Time frame: 24 hours

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

Time frame: 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

Time frame: 24 hours

Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits)

Data from ClinicalTrials.gov

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