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

Completed

Conditions: obesity
10003018

Registration Number: NL-OMON32430

Lead Sponsor: 7TM Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoint:<br /><br>To investigate effect of TM38337 on the central effect of THC using the<br /><br>following parameters:<br /><br>• Body Sway<br /><br>• VAS Bond and Lader (alertness, contentedness, calmness)<br /><br>• VAS Bowdle (internal/external perception, feeling high)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints:<br /><br>To investigate the effect of rimonabant on the central and heart rate effects<br /><br>(including BDI-II) of THC<br /><br>To explore the effect of TM38837 on THC induced effect on heart rate<br /><br><br /><br>The following pharmacokinetic parameters and dose-normalised pharmacokinetic<br /><br>parameters will be used for the characterisation of TM38837 as well as for THC:<br /><br>• Cmax<br /><br>• Tmax<br /><br>• T<br /><br>• AUC0*<br /><br><br /><br>• Subject incidence of AEs and SAEs<br /><br>• Number and percentage of subjects with clinically significant changes in<br /><br>vital signs (systolic blood pressure, diastolic blood pressure and pulse rate)<br /><br>• Number and percentage of subjects with clinically significant changes in ECG<br /><br>time intervals (PR, QRS, QT and QTc intervals)<br /><br>• Number and percentage of subjects with clinically significant changes in<br /><br>laboratory safety tests (haematology, clinical chemistry and urinalysis)</p><br>