Clinical Trial on Pharmacokinetics and Tolerability of AP707

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.

Inclusion criteria

• 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 criteria

• 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)