---
title: Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects
nct_id: NCT00581451
overall_status: COMPLETED
phase: PHASE1
sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
study_type: INTERVENTIONAL
primary_condition: Healthy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00581451.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00581451"
ct_last_update_post_date: 2009-07-10
last_seen_at: "2026-05-12T06:24:00.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects

**Official Title:** 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

**NCT ID:** [NCT00581451](https://clinicaltrials.gov/study/NCT00581451)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 144
- **Lead Sponsor:** Wyeth is now a wholly owned subsidiary of Pfizer
- **Conditions:** Healthy
- **Start Date:** 2007-10
- **Completion Date:** 2008-12
- **CT.gov Last Update:** 2009-07-10

## Brief Summary

Safety and tolerability study in healthy volunteers

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion criteria:

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

## Arms

- **A** (EXPERIMENTAL) — bifeprunox 25 day
- **B** (EXPERIMENTAL) — bifeprunox 14 day
- **C** (EXPERIMENTAL) — bifeprunox 14 day
- **D** (EXPERIMENTAL) — bifeprunox 9 day

## Interventions

- **bifeprunox** (DRUG) — oral tablet once daily

## Primary Outcomes

- **Tolerability** _(time frame: 28 days)_

## Secondary Outcomes

- **Safety** _(time frame: 28 days)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00581451.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00581451*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*