Pharmacokinetics of THCCOOH and Its Acyl-Glucuronide After Intravenous Administration of THCCOOH - Full Text View

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00176085

Purpose

A study on the fate and elimination of 11-Nor-9-carboxy-9-tetrahydrocannabinol was up to now not conducted, except of one single experiment in which (lacking) psychopharmacologi-cal 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

Condition	Phase
THCCOOH Pharmacokinetics Metabolism Cannabis	Phase I

Drug Information available for: Tetrahydrocannabinol Glutamic acid

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Prospective Study
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

Further study details as provided by University of Heidelberg:

Estimated Enrollment:	10
Study Start Date:	October 2004
Study Completion Date:	March 2005

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)

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176085

Locations

Germany
Clinical Research Center, Department of Internal Medicine VI
Heidelberg, Germany, 69120

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Gerd Mikus, MD BSc

Department of Internal Medicine VI

More Information

Study ID Numbers:	K107
Study First Received:	September 12, 2005
Last Updated:	April 16, 2007
ClinicalTrials.gov Identifier:	NCT00176085
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Tetrahydrocannabinol
Healthy

ClinicalTrials.gov processed this record on January 16, 2009