Pharmacokinetic Study to Characterize Individual Metabolic Profile (CIME1)

August 26, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Center of clinical investigation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one week
pharmacokinetic
Time Frame: one week
To determine which sampling times will provid the most pharmacokinetic information on the most compounds
one week
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
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Nuclear Energy Commission (CEA)

Investigators

  • Principal Investigator: DUVAL Xavier, doctor, Center of clinical investigation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 9, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (Estimated)

August 25, 2010

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C09-04
  • 2009-014866-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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