Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: ERB-257; Other: placebo

• Registration Number: NCT00722202
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-25
• Study Start: 2008-10
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-24
• Last Update Posted: 2009-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ERB-257	ERB-257	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
placebo	placebo	2 placebo subjects per group

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of ERB-257 as a single IV dose	4 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics of ERB-257 as a single IV dose	4 days

Trial Locations

Locations (1)

Sekino Clinical Pharmacology Clinic; 🇯🇵 Tokyo, Japan