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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176085
First Posted: September 15, 2005
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  Purpose

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 Phase
THCCOOH Pharmacokinetics Metabolism Cannabis Phase 1

Study Type: Observational
Study Design: 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

Further study details as provided by Heidelberg University:

Estimated Enrollment: 10
Study Start Date: October 2004
Study Completion Date: March 2005
Groups/Cohorts
healthy
healthy volunteers

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176085


Locations
Germany
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
  More Information

ClinicalTrials.gov Identifier: NCT00176085     History of Changes
Other Study ID Numbers: K107
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: May 28, 2015
Last Verified: May 2015