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

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ClinicalTrials.gov Identifier: NCT00722202
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : April 28, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Subjects Drug: ERB-257 Other: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : October 2008
Primary Completion Date : November 2008
Study Completion Date : November 2008
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. To evaluate the safety and tolerability of ERB-257 as a single IV dose [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics of ERB-257 as a single IV dose [ Time Frame: 4 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722202

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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00722202     History of Changes
Other Study ID Numbers: 3252K1-1001
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: April 28, 2009
Last Verified: April 2009