STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study (HNF4a)

Inje University

Status and phase: Completed; Phase 1

Conditions: Genotype Guided(HNF4a); Healthy Subjects

Treatments: Drug: Tolterodine

Study type: Interventional

Funder types: Other

Identifiers

NCT01181505

06-78

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subject whose HNF4a and CYP2D6 genotype ware determined

Exclusion criteria

• Subject whose HNF4a and CYP2D6 genotype ware not determined

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Tolterodine

Experimental group

Treatment:

Drug: Tolterodine