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

• Sponsor: Heidelberg University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00176085
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
THCCOOH; Pharmacokinetics; Metabolism; Cannabis

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 Design

• Study Type: Observational
• Time Perspective: Prospective
• 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
• Study Start Date: Oct 1, 2004
• Actual Study Completion Date: Mar 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
healthy healthy volunteers

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Center, Department of Internal Medicine VI	Heidelberg		Germany	69120

Sponsors and Collaborators

• Heidelberg University

Investigators

• Principal Investigator: Gerd Mikus, MD BSc, Department of Internal Medicine VI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00176085
• Other Study ID Numbers: K107
• First Posted: Sep 15, 2005
• Last Update Posted: May 28, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Marijuana Abuse

Study Results

No Results Posted as of May 28, 2015