Healthy Subjects Clinical Trial
Official title:
Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of ERB-257 Administered Intravenously as a 30-Minute Infusion to Healthy Japanese Male Subjects
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
Status | Completed |
Enrollment | 48 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Healthy Japanese men between the ages of 20 and 50. 2. 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. 3. Have a high probability for compliance with and completion of the study. Exclusion Criteria: 1. Presence or history of any disorder that may prevent the successful completion of the study. 2. Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Sekino Clinical Pharmacology Clinic | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the safety and tolerability of ERB-257 as a single IV dose | 4 days | No | |
Secondary | To evaluate the pharmacokinetics of ERB-257 as a single IV dose | 4 days | No |
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