Pharmacokinetics of THCCOOH and Its Acyl-Glucuronide After Intravenous Administration of THCCOOH
Information source: University of Heidelberg
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: THCCOOH; Pharmacokinetics; Metabolism; Cannabis
Phase: Phase 1
Status: Completed
Sponsored by: University of Heidelberg Official(s) and/or principal investigator(s):
Gerd Mikus, MD BSc, Principal Investigator, Affiliation: Department of Internal Medicine VI
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
Clinical Details
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 design: Screening, Cross-Sectional, Defined Population, Prospective Study
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
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
Locations and Contacts
Clinical Research Center, Department of Internal Medicine VI, Heidelberg 69120, Germany
Additional Information
Starting date: October 2004
Ending date: March 2005
Last updated: April 16, 2007
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