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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Codeine; Desvenlafaxine Succinate; Paroxetine

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.