NCT00581451

Brief Summary

Safety and tolerability study in healthy volunteers

Trial Health

100
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2007

Longer than P75 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

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

1.2 years

First QC Date

December 21, 2007

Last Update Submit

July 8, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Tolerability

    28 days

Secondary Outcomes (1)

  • Safety

    28 days

Study Arms (4)

A

EXPERIMENTAL

bifeprunox 25 day

Drug: bifeprunox

B

EXPERIMENTAL

bifeprunox 14 day

Drug: bifeprunox

C

EXPERIMENTAL

bifeprunox 14 day

Drug: bifeprunox

D

EXPERIMENTAL

bifeprunox 9 day

Drug: bifeprunox

Interventions

bifeprunoxDRUG

oral tablet once daily

ABCD

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male 18-50 years
  • Nonlactating female 18-50 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

bifeprunox

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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 27, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 10, 2009

Record last verified: 2009-07