Pharmacokinetic of Ten Parent Drugs and Their Metabolits in Order to Characterise Individual Metabolic Profile
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic parameters
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •healthy volunteers
Exclusion Criteria
- •pregnancy
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- pharmacokinetic(one week)
- Genotypes(one month)