Double-blind, randomized, balanced, placebo controlled, cross-over study of the effect of single oral administration of TM38837 and single oral rimonabant on inhaled tetrahydrocannabinol-induced effects in healthy male volunteers - Effect of TM38837 and rimonabant on THC-induced effects

7TM Pharma0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•1. Subject is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
•2. Legally competent non-african/afro-american/afro-caribebean healthy male with a BMI between 18-28.5 kg/m2, inclusive
•3. Age between 18-55 years, inclusive on the day the informed consent is signed.
•4. Mild cannabis user for at least one year: cannabis use of no more than once a week, and able to refrain from using cannabinoids from at least 2 weeks prior to the first treatment period to the end of the last study day.

•1. History of sensitivity/idiosyncrasy to THC, TM38837 or rimonabant, compounds chemically related to these compounds, or excipients which may be employed in the study or to any other relevant drug used in the past.
•2. Any clinically significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory, gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatologic (e.g. ancient surgically treated squamous cell carcinomas if considered significant), hematologic (including bleeding disorders), neurologic or psychiatric disease.
•3. First degree relative with significant psychiatric disorder

发起方