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

Pharmacokinetics Clinical Trial

Official title:

Pharmacokinetics of 11-Nor-9-carboxy-D9-tetrahydrocannabinol (THCCOOH) and Its Acyl-glucuronide (THCCOOH-GLu) After Intravenous Administration of THCCOOH in Healthy Human Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00176085
• Other study ID #: K107
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: May 27, 2015
• Start date: October 2004
• Est. completion date: March 2005

Study information

• Verified date: May 2015
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cannabis
• Metabolism
• Pharmacokinetics
• THCCOOH

Locations

Country	Name	City	State
Germany	Clinical Research Center, Department of Internal Medicine VI	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany,