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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181505
First Posted: August 13, 2010
Last Update Posted: August 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Inje University
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181505


Sponsors and Collaborators
Inje University
Investigators
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
ClinicalTrials.gov Identifier: NCT01181505     History of Changes
Other Study ID Numbers: 06-78
First Submitted: August 12, 2010
First Posted: August 13, 2010
Last Update Posted: August 13, 2010
Last Verified: November 2008

Keywords provided by Inje University:
HNF4a
CYP2D6
Toterodine
Genetic polymorphism

Additional relevant MeSH terms:
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents