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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722501
• Other study ID #: 3252K1-1000
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2008
• Last updated: April 24, 2009
• Start date: August 2008
• Est. completion date: November 2008

Study information

• Verified date: April 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• ERB-257

Other:
• placebo

Locations

Country	Name	City	State
United States	Trial Manager	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of single ascending IV doses of ERB-257 administered to healthy subjects		4 days per group	No
Secondary	To evaluate the pharmacokinetics of single ascending IV doses of ERB-257 administered to healthy subjects		4 days per group	No