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

July 23, 2008
April 24, 2009
October 2008
November 2008   (final data collection date for primary outcome measure)
To evaluate the safety and tolerability of ERB-257 as a single IV dose [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00722202 on ClinicalTrials.gov Archive Site
To evaluate the pharmacokinetics of ERB-257 as a single IV dose [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy Subjects
  • Drug: ERB-257
  • Other: placebo
  • 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
    Intervention: Drug: ERB-257
  • Placebo Comparator: placebo
    2 placebo subjects per group
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00722202
3252K1-1001
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP