Pharmacokinetic Study to Characterize Individual Metabolic Profile (CIME1)
The study aims to descibe the pharmacokinetics of 10 substrates of enzymes involved in drug metabolism and their metabolites, after administration singly and simultaenously at predefined doses in 10 health volunteers.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetic of Ten Parent Drugs and Their Metabolits in Order to Characterise Individual Metabolic Profile|
- Pharmacokinetic parameters [ Time Frame: one week ] [ Designated as safety issue: No ]The aim endpoint is based on the main pharmacokinetic parameters of each subject for all substrates and all metabolites. These main parameters are the area under the curve (AUC), the maximum concentration (Cmax), the half-life (T1/2)and the ratios of AUCs of the substrate and metabolites
- Tolerance of the concomittant administration of the 10 drugs: 1/number of volunteers with grade 4 adverse events 2/ number of volunteers with any adverse event, (grade 1 to grade 4) [ Time Frame: one week ] [ Designated as safety issue: Yes ]All clinical and biological adverse events will be recorded within the 7 days following drug administration.
- pharmacokinetic [ Time Frame: one week ] [ Designated as safety issue: No ]To determine which sampling times will provid the most pharmacokinetic information on the most compounds
- Genotypes [ Time Frame: one month ] [ Designated as safety issue: No ]Depending on the genotypes of the volunteers included, to evaluate the influence of these genotypes ont he pharmacokinetics of the substrates and their metabolites
|Study Start Date:||August 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Drug: 10 parents drugs adminstration
The aim of this study is to test the administration of combination of substrates and thereby to characterise simultaneously the main enzymes and transporters involved in drug metabolism. The doses of substrates administered will first assessed in terms of safety and their appropriateness for determination of pharmacokinetic parameters. Ten volunteers will be used, this number having been defined in view of the aims of this proof-of-concept pilot study,ie,safety and determination of pharmacokinetic parameters. The number was not the result of statistical calculation.
|Center of clinical investigation|
|Paris, France, 75018|
|Principal Investigator:||DUVAL Xavier, doctor||Center of clinical investigation|