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
  Purpose

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.


Condition Intervention Phase
Depressive Disorder, Major
Diabetic Neuropathies
Fibromyalgia
Vasomotor Symptoms
Drug: desvenlafaxine sustained release (DVS SR)
Drug: Paroxetine
Drug: Codeine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • the biotransformation of codeine to morphine and the safety and tolerability of DVS SR

Estimated Enrollment: 40
Study Start Date: January 2007
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456898

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00456898     History of Changes
Other Study ID Numbers: 3151A1-1203
Study First Received: April 4, 2007
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Diabetic Neuropathies
Fibromyalgia
Myofascial Pain Syndromes
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Codeine
Paroxetine
O-desmethylvenlafaxine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 15, 2014