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
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: 10 parents drugs adminstration
Phase 1

Study Type: Interventional
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

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 10
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 9, 2010
Last Updated: May 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 19, 2014