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

NCT ID: NCT00176085

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-03-31

Brief Summary

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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

Detailed Description

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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)

Conditions

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THCCOOH Pharmacokinetics Metabolism Cannabis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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healthy

healthy volunteers

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Gerd Mikus, MD BSc

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine VI

Locations

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Clinical Research Center, Department of Internal Medicine VI

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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K107

Identifier Type: -

Identifier Source: org_study_id

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