Pharmacokinetic Study to Characterize Individual Metabolic Profile (CIME1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01188525
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : May 15, 2012
Nuclear Energy Commission (CEA)
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

July 9, 2010
August 25, 2010
May 15, 2012
August 2010
July 2011   (Final data collection date for primary outcome measure)
Pharmacokinetic parameters [ Time Frame: one week ]
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
Same as current
Complete list of historical versions of study NCT01188525 on Archive Site
  • 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 ]
    All clinical and biological adverse events will be recorded within the 7 days following drug administration.
  • pharmacokinetic [ Time Frame: one week ]
    To determine which sampling times will provid the most pharmacokinetic information on the most compounds
  • Genotypes [ Time Frame: one month ]
    Depending on the genotypes of the volunteers included, to evaluate the influence of these genotypes ont he pharmacokinetics of the substrates and their metabolites
Same as current
Not Provided
Not Provided
Pharmacokinetic Study to Characterize Individual Metabolic Profile
Pharmacokinetic of Ten Parent Drugs and Their Metabolits in Order to Characterise Individual Metabolic Profile
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.
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.
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Volunteers
Drug: 10 parents drugs adminstration
A single and concomittant administration of 10 parent drugs will be performed: Acetaminophene, cafeine, dextrometorphan, digoxin, memantine,midazolam, omeprazole, repaglinide, rosuvastatine, tolbutamide.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • pregnancy
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
2009-014866-24 ( EudraCT Number )
Not Provided
Not Provided
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Nuclear Energy Commission (CEA)
Principal Investigator: DUVAL Xavier, doctor Center of clinical investigation
Institut National de la Santé Et de la Recherche Médicale, France
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP