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

Wyeth is now a wholly owned subsidiary of Pfizer48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Subjects

Interventions

ERB-257DRUG

placeboOTHER

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sekino Clinical Pharmacology Clinic

Tokyo, Japan

Outcomes

Primary Outcomes

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

Time frame: 4 days

Secondary Outcomes

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

Time frame: 4 days

Data from ClinicalTrials.gov

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