Pharmacokinetic Study to Characterize Individual Metabolic Profile

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT01188525
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2010-07-09
• Study Start: 2010-08
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-14
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters	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

Name	Time	Method
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)	one week	All clinical and biological adverse events will be recorded within the 7 days following drug administration.
pharmacokinetic	one week	To determine which sampling times will provid the most pharmacokinetic information on the most compounds
Genotypes	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

Trial Locations

Locations (1)

Center of clinical investigation; 🇫🇷 Paris, France