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Pharmacokinetic Study to Characterize Individual Metabolic Profile (CIME1)

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ClinicalTrials.gov Identifier: NCT01188525
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : May 15, 2012
Sponsor:
Collaborator:
Nuclear Energy Commission (CEA)
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: 10 parents drugs adminstration Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic of Ten Parent Drugs and Their Metabolits in Order to Characterise Individual Metabolic Profile
Study Start Date : August 2010
Primary Completion Date : July 2011
Study Completion Date : July 2011

Intervention Details:
    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.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. pharmacokinetic [ Time Frame: one week ]
    To determine which sampling times will provid the most pharmacokinetic information on the most compounds

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188525


Locations
France
Center of clinical investigation
Paris, France, 75018
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Nuclear Energy Commission (CEA)
Investigators
Principal Investigator: DUVAL Xavier, doctor Center of clinical investigation

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01188525     History of Changes
Other Study ID Numbers: C09-04
2009-014866-24 ( EudraCT Number )
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
pharmacokinetics
enzymes
metabolism prediction