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A Genotype Stratification Study for Pharmacokinetics and Pharmacodynamics of Amitriptyline in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT02519400
Recruitment Status : Unknown
Verified August 2015 by Hyeong-Seok Lim, Asan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Hyeong-Seok Lim, Asan Medical Center

Study Description
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Brief Summary:
A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline, 25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and cytochrome P450 2C19 genotypes, and serial blood sampling will be done for plasma concentrations of amitriptyline, nortriptyline, and their metabolites. Various pharmacodynamic markers related to the adverse event of amitriptyline will be measured serially during the study.

Condition or disease Intervention/treatment Phase
Depression Drug: Amitriptyline Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Single Dose, Double-blind, Genotype-based Stratification Study to Explore the Pharmacokinetics and Pharmacodynamics of Amitriptyline According to CYP2D6 and CYP2C19 Polymorphisms in Healthy Korean Male Adult Subjects
Study Start Date : August 2015
Estimated Primary Completion Date : October 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Amitriptyline
Single oral dose of amitriptyline, 25 mg
 Drug: Amitriptyline
Single oral dosing


Outcome Measures
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Primary Outcome Measures :
  1. Area under curve (AUC) of Amitriptyline, 10-Hydroxy-amitriptyline, Nortriptyline, and 10-Hydroxy-nortriptyline [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hour ]
  2. Maximum concentration (Cmax) of Amitriptyline, 10-Hydroxy-amitriptyline, Nortriptyline, and 10-Hydroxy-nortriptyline [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hour ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteer, age 19~45 years
  • The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
  • Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
  • Voluntarily signed the informed consent form

Exclusion Criteria:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
  • History of relevant drug allergies or clinically significant hypersensitivity reaction.
  • Smoked more than 10 cigarettes a day for past 3 months
  • Not eligible due to other reasons including laboratory results
Contacts and Locations
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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): NCT02519400


Contacts
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Contact: Shi Hyang Lee, MS 82-2-3010-4622 shlee@acp.kr

Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Hyeongseok Lim, MD, PhD Asan Medical Center, Ulsan University
More Information
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Responsible Party: Hyeong-Seok Lim, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02519400    
Other Study ID Numbers: PGAM-001
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015
Keywords provided by Hyeong-Seok Lim, Asan Medical Center:
amitriptyline
cyp2d6
cyp2c19
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Amitriptyline
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants