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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:
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT01181505
First received: August 12, 2010
Last updated: NA
Last verified: November 2008
History: No changes posted
  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
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181505

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

No publications provided

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
Study First Received: August 12, 2010
Last Updated: August 12, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Inje University:
HNF4a
CYP2D6
Toterodine
Genetic polymorphism

Additional relevant MeSH terms:
Tolterodine
Phenylpropanolamine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
 Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2013