Status:
COMPLETED
Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy Subjects
Eligibility:
MALE
20-50 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00722202
Start Date
October 1 2008
End Date
November 1 2008
Last Update
April 28 2009
Active Locations (1)
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1
Sekino Clinical Pharmacology Clinic
Tokyo, Japan, 1710014