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

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Sekino Clinical Pharmacology Clinic
Tokyo, , 1710014 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00722202
Pfizer
Completed
Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males

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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
Intervention Model: Single Group Assignment
Masking: Double
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.
Sexes Eligible for Study: Male
20 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00722202
3252K1-1001
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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