Clinical trial NCT00727064: Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects
Official title: A Randomized, Open-Label, Two-Period, Parallel Group, Crossover Study to Evaluate the Pharmacokinetics of Venlafaxine Extended-Release and DVS SR in Healthy Subjects Who Are Extensive or Poor Cytochrome P450 2D6 Substrate Metabolizers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if the relative difference in Pharmacokinetics (PK) between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women aged 18 to 55 years. Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
* History of being a nonsmoker for at least 1 year.
* Subjects have to be either extensive CYP2D6 metabolizers with a normal complement of 1 or 2 fully active enzyme gene alleles or poor CYP2D6 metabolizers (lack of active enzyme gene alleles) via genetic testing of a blood sample.

Exclusion Criteria:

* Presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease or any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure).
* Known or suspected alcohol abuse or consumption of more than 2 standard units per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine) within the past 6 months.
* Known or suspected current abuse of prohibited drugs or other substances. Use of any hormonal therapy within 30 days before study day -1 until the end of the partial inpatient confinement period.

Primary outcomes:
measure: Maximum Concentration (Cmax) of Venlafaxine After Single Dose of Venlafaxine Extended-release (VEN ER) by Metabolizer Status
timeFrame: single dose
measure: Area Under the Concentration-time Curve (AUC) of Venlafaxine After Single Dose of VEN ER by Metabolizer Status
timeFrame: single dose
measure: Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status
timeFrame: single dose
measure: Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status
timeFrame: single dose
measure: Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of Desvenlafaxine Succinate Sustained-Release (DVS SR) by Metabolizer Status
timeFrame: single dose
measure: Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of DVS SR by Metabolizer Status
timeFrame: single dose
Secondary outcomes:
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Clinical Research Institute
state: Kansas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: