Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males
NCT00722202
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- San Antonio, Texas
- New Haven, Connecticut
- Isumi-city, Chiba
- Matsuyama-city, Ehime
- Itoshima, Fukuoka
- Kasuga, Fukuoka
- Sapporo-city, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Kuwana, Mie
- Kurashiki, Okayama
- Okayama-city, Okayama
- Toyonaka, Osaka
- Kumagaya-city, Saitama
- Chiba,
- Fukuoka,
- Fukuoka,
- Fukuoka,
- Fukuoka,
- Funabashi, Chiba
- Isumi-city, Chiba
- Matsuyama-city, Ehime
- Higashi-ku, Fukuoka-city, Fukuoka
- Fukuyama, Hiroshima
- Kure, Hiroshima
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Kikuchi-gun, Kumamoto
- Suzuka, MIE
- Tsu, MIE
- Tsu, MIE
- Kumagaya-city, Saitama
- Kumagaya, Saitama
- Fuchu, Tokyo
- Ota-ku, Tokyo
- Setagaya-ku, Tokyo
- Setagaya-ku, Tokyo
- Tachikawa-shi, Tokyo
- Tama, Tokyo
- Kofu, Yamanashi
- Koushu-shi, Yamanashi
- Tsuru-shi, Yamanashi
- Fukuoka,
- Fukuoka,
- Kumamoto,
- Kumamoto,
- Kumamoto,
- Okayama,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males | |||
Official Title ICMJE | 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 | |||
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 | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Healthy Subjects | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 48 | |||
Original Estimated Enrollment ICMJE | 56 | |||
Actual Study Completion Date ICMJE | November 2008 | |||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00722202 | |||
Other Study ID Numbers ICMJE | 3252K1-1001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | April 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |