NCT00818155

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and the effects of the drug will also be evaluated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1 healthy

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

December 23, 2008

Last Update Submit

January 28, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results.

    2 months

Secondary Outcomes (1)

  • Pharmacokinetics as evaluated from blood and urine concentrations of desvenlafaxine

    2 months

Study Arms (2)

desvenlafaxine succinate SR

EXPERIMENTAL

desvenlafaxine succinate SR

Drug: desvenlafaxine succinate SR

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

desvenlafaxine succinate SRDRUG

desvenlafaxine succinate SR

desvenlafaxine succinate SR
PlaceboOTHER
Placebo

Eligibility Criteria

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

You may qualify if:

  • Men or non-pregnant, non-lactating women, 18 to 45 years of age inclusive on study day 1.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
  • Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) a day.

You may not qualify if:

  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • History of epilepsy or seizure disorder (except history of a single childhood febrile seizure).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2008

First Posted

January 7, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 29, 2013

Record last verified: 2013-01