Clinical trial NCT04708795: Clinical Trial on Pharmacokinetic and Tolerability of AP701
Official title: Clinical Trial on Pharmacokinetic and Tolerability of AP701
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic
Tolerability
Safety
Keywords: Cannabis
Cannabis based medicine
THC
Tetrahydrocannbinol
Lead sponsor: CannaXan GmbH
Sponsor class: INDUSTRY
First posted: 2021-01-14
Enrollment: 15
Sex: MALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Evaluation of pharmacokinetic parameter of THC (area under the curve)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration)
timeFrame: 30 hours
Secondary outcomes:
measure: Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of THC (area under the curve from 0 to 24 hours)
timeFrame: 24 hours
measure: Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from timepoint zero to quantification limits)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from 0 to 24 hours)
timeFrame: 24 hours
measure: Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of 11-OH-THC (time of last drug concentration above quantification limits)
timeFrame: 30 hours
measure: Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope)
timeFrame: 30 hours
measure: Adverse events (AE)
timeFrame: 30 hours
measure: Pschotropic drug effects measured by questionnaire
timeFrame: 30 hours
Other outcomes:
Locations:
city: Warngau
country: Germany
facility: Phase I Unit of CannaXan GmbH
state: Bavaria
Study officials:
affiliation: Phase I Unit of CannaXan GmbH
name: Stefan Lorenzl, PhD
role: PRINCIPAL_INVESTIGATOR
References: