A Genotype Stratification Study for Pharmacokinetics and... | NCT02519400

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

NCT02519400

Sponsor

Asan Medical Center

Status

Unknown status

Last Update Posted

Aug 11, 2015Estimated

Enrollment

24Estimated

Phase

Phase 1

Conditions

Depression

Interventions

Amitriptyline

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Oct 2015Estimated

Completion Date

Not provided

First Submitted Date

Aug 5, 2015

First Submission Date that Met QC Criteria

Aug 7, 2015

First Posted Date

Aug 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2015

Last Update Posted Date

Aug 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amitriptyline	Experimental	Single oral dose of amitriptyline, 25 mg	Drug: Amitriptyline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amitriptyline	Drug	Single oral dosing	Amitriptyline

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shi Hyang Lee, MS	Contact	82-2-3010-4622		shlee@acp.kr

Overall Officials

Name	Affiliation	Role
Hyeongseok Lim, MD, PhD	Asan Medical Center, Ulsan University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000639	Amitriptyline

Ancestor Terms

ID	Term
D003986	Dibenzocycloheptenes
D001567	Benzocycloheptenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided