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

Asan Medical Center

Status and phase

Unknown

Phase 1

Conditions

Depression

Treatments

Drug: Amitriptyline

Study type

Interventional

Funder types

Other

Identifiers

NCT02519400

PGAM-001

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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