Status:
COMPLETED
Clinical Trial on Pharmacokinetic and Tolerability of AP701
Lead Sponsor:
CannaXan GmbH
Conditions:
Pharmacokinetic
Tolerability
Eligibility:
MALE
35-60 years
Phase:
PHASE1
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
- Signed and dated informed consent form
- Male in the age of 35 - 60 year at study start
- Body mass index of 18 to 30 kg/m2
- Non-smoker, no use of any Tabaco products
- Good general health status (Karnofsky Score = 100)
- Current ECG without abnormal findings (i.a. QTcF \< 450 ms)
- Physical examination, medical history without exclusionary findings
- Pulse rate between 50 and 90 bpm
- Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg
- Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges
- Lab values for renal function (S-Creatinine, eGFR) within normal range
- Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody
- Negative test result of urine screening for Cannabis, alcohol, and substance abuse
Exclusion
- Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- Use of Cannabis products within the last 8 weeks
- Use of opioids
- Former or present dependency (e.g. to alcohol, medicinal products, drugs)
- Participation in another clinical trial within the last four weeks prior to study inclusion
- Present, former, or family history of mental illnesses such as severe de pression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
- Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
- Body temperature ≥ 38 °C
- Present cardiovascular, respiratory, diabetic, or cancer disease
- Hepatitis or other liver and renal disease
- 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
- Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
- Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)
Key Trial Info
Start Date :
January 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04708795
Start Date
January 11 2020
End Date
March 7 2021
Last Update
March 10 2021
Active Locations (1)
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1
Phase I Unit of CannaXan GmbH
Warngau, Bavaria, Germany, D-83627