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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01181505

Acronym

HNF4a

Enrollment

Registered

2010-08-13

Start date

2007-01-31

Completion date

2008-06-30

Last updated

2010-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genotype Guided(HNF4a), Healthy Subjects

Keywords

HNF4a, CYP2D6, Toterodine, Genetic polymorphism

Brief summary

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.

Detailed description

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.

Interventions

DRUGTolterodine

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy subject whose HNF4a and CYP2D6 genotype ware determined

Exclusion criteria

* Subject whose HNF4a and CYP2D6 genotype ware not determined

Design outcomes

Primary

Measure	Time frame
Cmax, AUC, CL, Vd, T1/2	24hr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026