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Pharmacokinetic Study to Characterize Individual Metabolic Profile (CIME1)

This study has been completed.
Sponsor:
Collaborator:
Nuclear Energy Commission (CEA)
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01188525
First received: July 9, 2010
Last updated: May 14, 2012
Last verified: May 2012
History of Changes

July 9, 2010
May 14, 2012
August 2010
July 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01188525 on ClinicalTrials.gov 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 ] [ 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
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.
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • pregnancy
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01188525
C09-04, 2009-014866-24
Yes
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