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Completed

NCT Number: NCT01181505

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

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.

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Key information

Conditions

Genotype Guided(HNF4a) Healthy Subjects

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subject whose HNF4a and CYP2D6 genotype ware determined

Exclusion criteria

  • Subject whose HNF4a and CYP2D6 genotype ware not determined

Treatment and study plan

tolterodine

Drug

Primary outcomes

  1. Cmax, AUC, CL, Vd, T1/2

    Time frame: 24hr

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Acronym: HNF4a

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2010
Registry last updated
Aug 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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