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

This study is currently recruiting participants.

Verified by Wyeth, November 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00722202

Purpose

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

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety Study
Official Title:	Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of ERB-257 Administered Intravenously as a 30-Minute Infusion to Healthy Japanese Male Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

To evaluate the safety and tolerability of ERB-257 as a single IV dose [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the pharmacokinetics of ERB-257 as a single IV dose [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 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

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Japanese men between the ages of 20 and 50.
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.
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, infection, fever, or diarrhea) within 7 days before study day 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722202

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Japan
Sekino Clinical Pharmacology Clinic	Recruiting
Tokyo, Japan, 1710014
Contact: Trial Manager clinicaltrialparticipation@wyeth.com

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3252K1-1001
Study First Received:	July 23, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00722202
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009