Pharmacokinetic Study to Characterize Individual Metabolic Profile (CIME1)

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

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: 10 parents drugs adminstration

Study type: Interventional

Funder types: Other

Identifiers

NCT01188525

C09-04

2009-014866-24 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers

Exclusion criteria

• pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)