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CompletedNCT01181505HNF4aUpdated Aug 13, 2010

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

A Phase 1 interventional study of Tolterodine in Genotype Guided(HNF4a) and Healthy Subjects, sponsored by Inje University. Completed. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-13.

Sponsored by Inje University · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Ages
20 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Genotype Guided(HNF4a)
  • Healthy Subjects

Keywords

  • HNF4a
  • CYP2D6
  • Toterodine
  • Genetic polymorphism
03

In context

Lead sponsor

Inje University is the lead sponsor of 90 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subject whose HNF4a and CYP2D6 genotype ware determined

Exclusion criteria

Exclusion Criteria:

  • Subject whose HNF4a and CYP2D6 genotype ware not determined
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Tolterodine

    Drug: Tolterodine

Interventions

  • DrugTolterodine
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What researchers measure

Primary outcomes

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

    Time frame: 24hr

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01181505
Lead sponsor
Inje University
First posted
Aug 13, 2010
Start date
Jan 2007
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Aug 13, 2010

Study contacts

Jae-Gook Shin, MD, PhD
principal investigator · Inje University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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