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

Depression Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02519400
• Other study ID #: PGAM-001
• Status: Not yet recruiting
• Phase: Phase 1
• First received: August 5, 2015
• Last updated: August 9, 2015
• Start date: August 2015

Study information

• Verified date: August 2015
• Source: Asan Medical Center
• Contact: Shi Hyang Lee, MS
• Phone: 82-2-3010-4622
• Email: shlee[@]acp.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• Amitriptyline
Single oral dosing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No