Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects

A 3-Part, Randomized, Multiple-Dose, Sequential Design Study of Bifeprunox in Healthy Subjects in Order to Establish a Titration Regimen With an Improved Tolerability Profile

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00581451

Enrollment

144

Registered

2007-12-27

Start date

2007-10-31

Completion date

2008-12-31

Last updated

2009-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

Safety and tolerability study in healthy volunteers

Interventions

DRUGbifeprunox

oral tablet once daily

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Tolerability	28 days

Secondary

Measure	Time frame
Safety	28 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026