Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT03054220
Brief Summary:
CYP2D6 is characterized by a huge variability in the general population, mainly because of genetic polymorphism and drug-drug interactions (DDIs). CYP2D6 genotype is known to have an impact on the extent of DDIs. Indeed several studies have pointed out differential DDIs extent according to CYP2D6 genotype. The terms phenoconversion and phenotype switch are both used to describe the phenomenon by which a given subject changes his phenotype to another due external influence such as DDIs. When given a sufficiently strong CYP2D6 inhibitor, the phenotype of an individual with no mutant allele (extensive metabolizer, EM) of CYP2D6 can be modified to a poor metabolizer (PM) phenotype. This vulnerability is also thought to be dependent on CYP2D6 genotype. Various combinations of alleles predict an EM genotype, which represents about 60 to 70% of the general population. The aim of the study is to determine whether the presence of genetic mutation in CYP2D6 has an impact on DDIs involving the CYP2D6 enzyme. Our interest focuses on CYP2D6 EM carriers of two fully functional alleles and carriers of one non-functional and one functional allele. In order to elucidate this question, CYP2D6 activity will be measured on healthy volunteers by administration of single low doses of dextromethorphan and tramadol in presence or not of duloxetine and paroxetine, two known CYP2D6 inhibitors.
Study:
NCT03054220
Study Brief:
Protocol Section:
NCT03054220