NCT00722202

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV administered ERB-257 as single ascending doses to healthy Japanese male subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

April 28, 2009

Status Verified

April 1, 2009

Enrollment Period

1 month

First QC Date

July 23, 2008

Last Update Submit

April 24, 2009

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and tolerability of ERB-257 as a single IV dose

    4 days

Secondary Outcomes (1)

  • To evaluate the pharmacokinetics of ERB-257 as a single IV dose

    4 days

Study Arms (2)

ERB-257

ACTIVE COMPARATOR

7 IV single doses of ERB-257 will be given to 6 healthy subjects per group - 1, 4, 15, 45, 90, 180, and 300 mg

Drug: ERB-257

placebo

PLACEBO COMPARATOR

2 placebo subjects per group

Other: placebo

Interventions

ERB-257DRUG
ERB-257
placeboOTHER
placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Japanese men between the ages of 20 and 50.
  • Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg2.
  • Have a high probability for compliance with and completion of the study.

You may not qualify if:

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sekino Clinical Pharmacology Clinic

Tokyo, 1710014, Japan

Location

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
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

April 28, 2009

Record last verified: 2009-04

Locations

JP(1)