STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study

Inje University31 enrolled

Overview

This study was to investigate the pharmacokinetics of tolterodine, substrate of CYP2D6 in healthy subject in relation to the presence of HNF-4A G60D variant.

After a single oral administration of 2 mg tolterodine in 31 healthy subjects (6 with the heterozygous mutation of HNF-4A G60D vs 25 subjects with wild type of that whose CYP2D6 genotype and gender were matched with variant group), blood were collected for 24hrs. Assay of tolterodine and the metabolite, 5-hyroxymethyl tolterodine was conducted using LC/MS/MS.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Genotype Guided(HNF4a)Healthy Subjects

Interventions

TolterodineDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subject whose HNF4a and CYP2D6 genotype ware determined Exclusion Criteria: * Subject whose HNF4a and CYP2D6 genotype ware not determined

Outcomes

Primary Outcomes

Cmax, AUC, CL, Vd, T1/2

Time frame: 24hr

Data from ClinicalTrials.gov

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