NCT00456898

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

April 4, 2007

Last Update Submit

December 19, 2007

Conditions

Depressive Disorder, MajorDiabetic NeuropathiesFibromyalgiaVasomotor Symptoms

Outcome Measures

Primary Outcomes (1)

  • the biotransformation of codeine to morphine and the safety and tolerability of DVS SR

Interventions

desvenlafaxine sustained release (DVS SR)DRUG
ParoxetineDRUG
CodeineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, MajorDiabetic NeuropathiesFibromyalgia

Interventions

ParoxetineCodeine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesMuscular DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

January 1, 2007

Study Completion

March 1, 2007

Last Updated

December 28, 2007

Record last verified: 2007-12