CTH120 First-in-Human Study: Single and Multiple Ascending Doses and Potential Food Interaction

Exclusion Criteria

• •Women of child-bearing potential.
• •Life-time substance use disorders (SUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
• •Recreational use of drugs of abuse within the last month prior to study drug administration (verified by hair testing).
• •Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration.
• •Life-time history of mental diseases.
• •History of anxiety or depression not completely recovered within 12 months prior to study drug administration, as assessed by the Dual Diagnosis Screening Interview (DDSI).
• •Clinically relevant cognitive impairment preventing the administration of the psychometric tests.
• •Any other clinically relevant disease or condition that in the judgment of the investigator might interfere with the subject's ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject's safety.
• •Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption.
• •Subjects with a clinically significant disease within one month prior to study drug administration.
• •Any clinically relevant findings in physical examination, vital signs, ECG and safety laboratory parameters.
• •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms).
• •A history of additional risk factors for TdP (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome).
• •The use of concomitant medications that prolong the QT/QTc interval.
• •Positive hepatitis or HIV test.
• •Known hypersensitivity to drug or drug excipients.
• •Use of drugs known to induce or inhibit hepatic drug metabolism within one month prior to study administration or during the study and use of citrus juice during the study.
• •Any prescription or over-the-counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements within 2 weeks (or more, considering the elimination half-life of the product) prior to study drug administration.
• •Donation of blood or plasma within one month prior to study drug administration or transfusion of blood or plasma for medical/surgical reasons or intention to donate blood or plasma within one month after study drug administration.
• •History of inadequate venous access and/or experience of difficulty donating blood.
• •Not able/not willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items when out of CRU.
• •Subject included in a clinical study within 3 months prior to study drug administration.
• •Subject already included in other parts of this study.