Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH

Completed

• Conditions: Pharmacokinetics; Metabolism; THCCOOH; Cannabis

• Registration Number: NCT00176085
• Lead Sponsor: Heidelberg University

Brief Summary

A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to now not conducted, except of one single experiment in which (lacking) psychopharmacological activity was tested after intravenous infusion of 20 mg in a human individual. In this study, however, the authors did not trace the above questions due to analytical and methodological deficits.

Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after intravenous ad-ministration of 5 mg THCCOOH in healthy individuals

Detailed Description

To determine the pharmacokinetics of THCCOOH after intravenous administration of THCCOOH (5 mg) and its formed glucuronide in healthy individuals in order to improve the possibilities for the assessment of unfitness to drive. For these purposes the following criteria will be studied:

THCCOOH

* Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)

* Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution of (Vc) Formed THCCOOH-glu

* Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)

* Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution (Vc)

Study Timeline

• Study Start: 2004-10
• Study Completion: 2005-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Good state of health (physically and mentally)

Exclusion Criteria

• Any regular drug treatment within the last two months
• Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport systems within a period of less than 10 times the respective elimination half-life
• Any acute or chronic illness or clinically relevant findings in the pre-study examination
• Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
• Smoking (regular or irregular)
• Excessive alcohol drinking (more than approximately 30 g alcohol per day)
• Positive drug screening especially THC or known or admitted drug abuse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Clinical Research Center, Department of Internal Medicine VI; 🇩🇪 Heidelberg, Germany