Back to resultsStudy Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
Primary Purpose
Depressive Disorder, Major, Diabetic Neuropathies, Fibromyalgia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
desvenlafaxine sustained release (DVS SR)
Paroxetine
Codeine
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major
Eligibility Criteria
Inclusion criteria:
- Healthy men and nonlactating and nonpregnant women of nonchildbearing potential aged from 18 to 45 years.
- Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.
Exclusion criteria:
- History of bronchial asthma, of seizure disorder (other than a single childhood febrile seizure)and of any clinically important drug allergy and any known allergy to desvenlafaxine, venlafaxine, paroxetine, codeine, or any of the non-active excipients in the dosage forms.
- Use of any CYP2D6 inhibitors or inducers within 30 days before test article administration.
- Demonstration of a positive orthostatic test at screening.
Sites / Locations
Outcomes
Primary Outcome Measures
the biotransformation of codeine to morphine and the safety and tolerability of DVS SR
Secondary Outcome Measures
Full Information
NCT ID
NCT00456898
First Posted
April 4, 2007
Last Updated
December 19, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00456898
Brief Title
Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
Official Title
A Randomized, Open-Label, 3-Period Crossover Study to Evaluate the Effect of Multiple Doses of DVS SR and Paroxetine on the CYP2D6 Biotransformation of Codeine to Morphine in Healthy Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To evaluate the effects of multiple oral doses of desvenlafaxine sustained release (DVS SR) and paroxetine on the biotransformation of codeine to morphine in healthy subjects. To assess the safety and tolerability of DVS SR and paroxetine when coadministered with codeine to healthy subjects.
Detailed Description
This is a randomized, open-label, inpatient/outpatient, 3-period crossover study in healthy subjects.The study will consist of 3 treatment periods. In treatment period 1, subjects will be randomly assigned on study day 1. A single 60-mg dose of codeine will be administered to all subjects. In periods 2 and 3, subjects will receive either DVS SR 100 mg/day or paroxetine 20 mg/day until the steady state is reached. At steady state, subjects will receive codeine 60 mg concomitantly with either DVS SR 100 mg or paroxetine 20 mg, depending on the treatment sequence to which they are assigned. DVS SR 100 mg or paroxetine 20 mg administration will continue for an additional 2 days. In treatment period 3, subjects will receive the alternative treatment sequence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Diabetic Neuropathies, Fibromyalgia, Vasomotor Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
desvenlafaxine sustained release (DVS SR)
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Type
Drug
Intervention Name(s)
Codeine
Primary Outcome Measure Information:
Title
the biotransformation of codeine to morphine and the safety and tolerability of DVS SR
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Healthy men and nonlactating and nonpregnant women of nonchildbearing potential aged from 18 to 45 years.
Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.
Exclusion criteria:
History of bronchial asthma, of seizure disorder (other than a single childhood febrile seizure)and of any clinically important drug allergy and any known allergy to desvenlafaxine, venlafaxine, paroxetine, codeine, or any of the non-active excipients in the dosage forms.
Use of any CYP2D6 inhibitors or inducers within 30 days before test article administration.
Demonstration of a positive orthostatic test at screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
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