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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02519400

Enrollment

Registered

2015-08-10

Start date

2015-08-31

Completion date

Unknown

Last updated

2015-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

amitriptyline, cyp2d6, cyp2c19

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.

Interventions

DRUGAmitriptyline

Single oral dosing

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
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

Contacts

Primary ContactShi Hyang Lee, MS

shlee@acp.kr82-2-3010-4622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026