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

Fibromyalgia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456898
• Other study ID #: 3151A1-1203
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2007
• Last updated: December 19, 2007
• Start date: January 2007
• Est. completion date: March 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Diabetic Neuropathies
• Fibromyalgia
• Vasomotor Symptoms

Intervention

Drug:
• desvenlafaxine sustained release (DVS SR)

• Paroxetine

• Codeine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the biotransformation of codeine to morphine and the safety and tolerability of DVS SR