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

This study has been completed.
Information provided by:
Inje University Identifier:
First received: August 12, 2010
Last updated: NA
Last verified: November 2008
History: No changes posted
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.

Condition Intervention Phase
Genotype Guided(HNF4a)
Healthy Subjects
Drug: Tolterodine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study

Resource links provided by NLM:

Further study details as provided by Inje University:

Primary Outcome Measures:
  • Cmax, AUC, CL, Vd, T1/2 [ Time Frame: 24hr ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolterodine Drug: Tolterodine

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.

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01181505

Sponsors and Collaborators
Inje University
Principal Investigator: Jae-Gook Shin, MD, PhD Inje University
  More Information

Responsible Party: Department of Pharmacology and PharmacoGenomics Research Center, Inje University College of Medicine Identifier: NCT01181505     History of Changes
Other Study ID Numbers: 06-78 
Study First Received: August 12, 2010
Last Updated: August 12, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Inje University:
Genetic polymorphism

Additional relevant MeSH terms:
Tolterodine Tartrate
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Physiological Effects of Drugs
Urological Agents processed this record on May 25, 2016