Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00456898
First received: April 4, 2007
Last updated: December 19, 2007
Last verified: December 2007

April 4, 2007
December 19, 2007
January 2007
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the biotransformation of codeine to morphine and the safety and tolerability of DVS SR
Same as current
Complete list of historical versions of study NCT00456898 on ClinicalTrials.gov Archive Site
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Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depressive Disorder, Major
  • Diabetic Neuropathies
  • Fibromyalgia
  • Vasomotor Symptoms
  • Drug: desvenlafaxine sustained release (DVS SR)
  • Drug: Paroxetine
  • Drug: Codeine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2007
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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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00456898
3151A1-1203
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Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP