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

Sponsor

Asan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02519400

Collaborator

(none)

Enrollment

Arm

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amitriptyline Single oral dose of amitriptyline, 25 mg	Drug: Amitriptyline Single oral dosing

Arm

Intervention/Treatment

Experimental: Amitriptyline

Single oral dose of amitriptyline, 25 mg

Drug: Amitriptyline

Single oral dosing

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

Asan Medical Center

Investigators

Principal Investigator: Hyeongseok Lim, MD, PhD, Asan Medical Center, Ulsan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyeong-Seok Lim, Associate Professor, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT02519400

Other Study ID Numbers:

PGAM-001

First Posted:

Aug 10, 2015

Last Update Posted:

Aug 11, 2015

Last Verified:

Aug 1, 2015

Keywords provided by Hyeong-Seok Lim, Associate Professor, Asan Medical Center

amitriptyline

cyp2d6

cyp2c19

Additional relevant MeSH terms:

Depression

Amitriptyline

Study Results

No Results Posted as of Aug 11, 2015