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

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00722501

Purpose

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

Condition	Intervention	Phase
Healthy Subjects	Drug: ERB-257 Other: placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Single Group Assignment, Safety Study
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

Further study details as provided by Wyeth:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the pharmacokinetics of single ascending IV doses of ERB-257 administered to healthy subjects [ Time Frame: 4 days per group ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	August 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ERB-257: Active Comparator 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	Drug: ERB-257
placebo: Placebo Comparator 2 placebo subjects per group	Other: placebo

Eligibility

Criteria

Inclusion Criteria:

Healthy men and women of non-childbearing potential between the ages of 18 and 50.
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.
Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

Presence or history of any disorder that may prevent the successful completion of the study.
Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722501

Locations

United States, Pennsylvania
Trial Manager
Philadelphia, Pennsylvania, United States, 19148

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3252K1-1000
Study First Received:	July 23, 2008
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00722501 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009