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

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

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: desvenlafaxine; Drug: desvenlafaxine; Drug: desvenlafaxine

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 mg	Drug: desvenlafaxine; one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days; Drug: desvenlafaxine; one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days; Drug: desvenlafaxine; two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days
Experimental: 100 mg	Drug: desvenlafaxine; one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days; Drug: desvenlafaxine; one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days; Drug: desvenlafaxine; two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days
Experimental: 200 mg	Drug: desvenlafaxine; one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days; Drug: desvenlafaxine; one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days; Drug: desvenlafaxine; two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
For single dose: maximum concentration (Cmax)	day 1
For single dose: time to first occurence of Cmax (Tmax)	day 1
For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)	day 1
For multiple dose: maximum concentration (Cmax)	day 8
For multiple dose: time to first occurence of Cmax (Tmax)	day 8
For multiple dose: trough concentration (Ctrough)	day 8
For multiple dose: area under curve (0-24hours) (AUC0-24)	day 8

Secondary Outcome Measures

Outcome Measure	Time Frame
For single dose if data permit: terminal elimination half life (t1/2)	day 1
For single dose if data permit: area under curve (0-infinity) (AUCinf)	day 1
For single dose if data permit: oral clearance (CL/F)	day 1
For single dose if data permit: apparent volume of distribution (Vz/F)	day 1
For multiple dose if data permit: accumulation factor (Rac)	day 8
For multiple dose if data permit: terminal elimination half life (t1/2)	day 8
For multiple dose if data permit: oral clearance (CL/F)	day 8
For multiple dose if data permit: apparent volume of distribution (Vz/F)	day 8

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimate): September 29, 2011

Study Record Updates

• Last Update Posted (Estimate): January 2, 2012
• Last Update Submitted That Met QC Criteria: December 29, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: safety; pharmacokinetics; desvenlafaxine; Korean healthy subjects
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Desvenlafaxine Succinate
• Other Study ID Numbers: B2061137