- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00456898
Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
December 19, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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.
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
40
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
the biotransformation of codeine to morphine and the safety and tolerability of DVS SR
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
April 4, 2007
First Submitted That Met QC Criteria
April 4, 2007
First Posted (Estimate)
April 5, 2007
Study Record Updates
Last Update Posted (Estimate)
December 28, 2007
Last Update Submitted That Met QC Criteria
December 19, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Mood Disorders
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Depressive Disorder
- Fibromyalgia
- Depressive Disorder, Major
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Cytochrome P-450 CYP2D6 Inhibitors
- Respiratory System Agents
- Antitussive Agents
- Paroxetine
- Desvenlafaxine Succinate
- Codeine
Other Study ID Numbers
- 3151A1-1203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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