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

Last updated on December 7, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder, Diabetic Neuropathies, Fibromyalgia, Vasomotor Symptoms
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00456898
Pfizer
Completed
Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway

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Descriptive Information
Brief Title  ICMJE Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
Official Title  ICMJE 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.
Brief SummaryTo 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.
Detailed DescriptionThis 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Disorder, Major
  • Diabetic Neuropathies
  • Fibromyalgia
  • Vasomotor Symptoms
Intervention  ICMJE
  • Drug: desvenlafaxine sustained release (DVS SR)
  • Drug: Paroxetine
  • Drug: Codeine
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: April 4, 2007)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00456898
Other Study ID Numbers  ICMJE 3151A1-1203
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

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