Trials / Completed
CompletedNCT00176085
Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH
Pharmacokinetics of 11-Nor-9-carboxy-D9-tetrahydrocannabinol (THCCOOH) and Its Acyl-glucuronide (THCCOOH-GLu) After Intravenous Administration of THCCOOH in Healthy Human Subjects
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (planned)
- Sponsor
- Heidelberg University · Academic / Other
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
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)
Conditions
Timeline
- Start date
- 2004-10-01
- Completion
- 2005-03-01
- First posted
- 2005-09-15
- Last updated
- 2015-05-28
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00176085. Inclusion in this directory is not an endorsement.