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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00722202
First received: July 23, 2008
Last updated: April 24, 2009
Last verified: April 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 is now a wholly owned subsidiary of Pfizer:

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 ]

Enrollment: 48
Study Start Date: October 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: ERB-257
Placebo Comparator: placebo
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Sekino Clinical Pharmacology Clinic
Tokyo, Japan, 1710014
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00722202     History of Changes
Other Study ID Numbers: 3252K1-1001
Study First Received: July 23, 2008
Last Updated: April 24, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on August 28, 2014