Status:
COMPLETED
Clinical Trial on Pharmacokinetics and Tolerability of AP707
Lead Sponsor:
CannaXan GmbH
Conditions:
Pharmacokinetics
Tolerability
Eligibility:
MALE
30-60 years
Phase:
PHASE1
Brief Summary
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.
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.
Eligibility Criteria
Inclusion
- Signed and dated informed consent form
- Male at the age of 30 - 60 years at study start
- Body mass index of 18 to 30 kg/m2
- Non-smoker, no use of any tobacco products,
- Good general health status (Karnofsky Score = 100; see Annex 1, page 59)
- Current ECG without abnormal findings (no significant alterations from normal values, especially with regard to the QT interval (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 value for renal function (S-Creatinine, eGFR according to CKD-EPI) 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 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
- Former or present mental illnesses such as severe depression, 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 A, B, C 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 :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05267769
Start Date
March 2 2022
End Date
April 3 2022
Last Update
July 27 2022
Active Locations (1)
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1
Phase I Unit of CannaXan GmbH
Warngau, Bavaria, Germany, 83627