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NCT00176085 Clinical Trial

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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00176085
Other study ID # K107
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2005
Last updated May 27, 2015
Start date October 2004
Est. completion date March 2005

Study information
Verified date May 2015
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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

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)

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Clinical Research Center, Department of Internal Medicine VI Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

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