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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

April 16, 2007

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00176085 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Pharmacokinetics of 11-Nor-9-Carboxy-D9-Tetrahydrocannabinol (THCCOOH) and Its Acyl-Glucuronide (THCCOOH-GLu) After Intravenous Administration of THCCOOH in Healthy Human Subjects

Brief Summary

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

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 Phase

Phase I

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening, Cross-Sectional, Defined Population, Prospective Study

Condition ^ICMJE

THCCOOH
Pharmacokinetics
Metabolism
Cannabis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00176085

Responsible Party

Study ID Numbers ^ICMJE

K107

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Gerd Mikus, MD BSc

Department of Internal Medicine VI

Information Provided By

University of Heidelberg

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP