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Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

desvenlafaxine

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring pharmacokinetics, safety, desvenlafaxine, Korean healthy subjects

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male and/or female subjects
Between the ages of 18 and 55 years, inclusive
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

Elevated risk of suicide, in the opinion of the investigator or expert consultant
Pregnant or nursing females
Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

50 mg

100 mg

200 mg

Arm Description

Outcomes

Primary Outcome Measures

For single dose: maximum concentration (Cmax)

For single dose: time to first occurence of Cmax (Tmax)

For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)

For multiple dose: maximum concentration (Cmax)

For multiple dose: time to first occurence of Cmax (Tmax)

For multiple dose: trough concentration (Ctrough)

For multiple dose: area under curve (0-24hours) (AUC0-24)

Secondary Outcome Measures

For single dose if data permit: terminal elimination half life (t1/2)

For single dose if data permit: area under curve (0-infinity) (AUCinf)

For single dose if data permit: oral clearance (CL/F)

For single dose if data permit: apparent volume of distribution (Vz/F)

For multiple dose if data permit: accumulation factor (Rac)

For multiple dose if data permit: terminal elimination half life (t1/2)

For multiple dose if data permit: oral clearance (CL/F)

For multiple dose if data permit: apparent volume of distribution (Vz/F)

Full Information

NCT ID

NCT01443208

First Posted

September 23, 2011

Last Updated

December 29, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01443208

Brief Title

Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet

Official Title

A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

pharmacokinetics, safety, desvenlafaxine, Korean healthy subjects

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50 mg

Arm Type

Experimental

Arm Title

100 mg

Arm Type

Experimental

Arm Title

200 mg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

desvenlafaxine

Intervention Description

one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days

Intervention Type

Drug

Intervention Name(s)

desvenlafaxine

Intervention Description

one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days

Intervention Type

Drug

Intervention Name(s)

desvenlafaxine

Intervention Description

two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days

Primary Outcome Measure Information:

Title

For single dose: maximum concentration (Cmax)

Time Frame

day 1

Title

For single dose: time to first occurence of Cmax (Tmax)

Time Frame

day 1

Title

For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)

Time Frame

day 1

Title

For multiple dose: maximum concentration (Cmax)

Time Frame

day 8

Title

For multiple dose: time to first occurence of Cmax (Tmax)

Time Frame

day 8

Title

For multiple dose: trough concentration (Ctrough)

Time Frame

day 8

Title

For multiple dose: area under curve (0-24hours) (AUC0-24)

Time Frame

day 8

Secondary Outcome Measure Information:

Title

For single dose if data permit: terminal elimination half life (t1/2)

Time Frame

day 1

Title

For single dose if data permit: area under curve (0-infinity) (AUCinf)

Time Frame

day 1

Title

For single dose if data permit: oral clearance (CL/F)

Time Frame

day 1

Title

For single dose if data permit: apparent volume of distribution (Vz/F)

Time Frame

day 1

Title

For multiple dose if data permit: accumulation factor (Rac)

Time Frame

day 8

Title

For multiple dose if data permit: terminal elimination half life (t1/2)

Time Frame

day 8

Title

For multiple dose if data permit: oral clearance (CL/F)

Time Frame

day 8

Title

For multiple dose if data permit: apparent volume of distribution (Vz/F)

Time Frame

day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male and/or female subjects Between the ages of 18 and 55 years, inclusive Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) Exclusion Criteria: Elevated risk of suicide, in the opinion of the investigator or expert consultant Pregnant or nursing females Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2061137&StudyName=Pharmacokinetics%20and%20Safety%20of%20Desvenlafaxine%20in%20Korean%20Healthy%20Subjects%20Following%20Single%20and%20Multiple%20Oral%20Doses%20of%20Desvenlafaxine%20Succinat

Description

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Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet

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