Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257

Overview

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

Full Title of Study: “Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ERB-257 Administered Intravenously as a 30-Minute Infusion to Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: November 2008

Interventions

  • Drug: ERB-257
  • Other: placebo

Arms, Groups and Cohorts

  • Active Comparator: 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 Comparator: placebo
    • 2 placebo subjects per group

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate the safety and tolerability of single ascending IV doses of ERB-257 administered to healthy subjects
    • Time Frame: 4 days per group

Secondary Measures

  • To evaluate the pharmacokinetics of single ascending IV doses of ERB-257 administered to healthy subjects
    • Time Frame: 4 days per group

Participating in This Clinical Trial

Inclusion Criteria

1. Healthy men and women of non-childbearing potential between the ages of 18 and 50. 2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 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, fever, or diarrhea) within 7 days before study day 1.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wyeth is now a wholly owned subsidiary of Pfizer
  • Provider of Information About this Clinical Study
    • Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
  • Overall Official(s)
    • Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer

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