Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects
NCT00854009
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1. Men, aged 20 to 50 years of age inclusive at screening.
2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.
3. Healthy as determined by the investigator on the basis of the screening evaluations.
4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.
1. Presence of history of any disorder that may prevent the successful completion of the
study.
2. History of drug abuse within 1 year.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects | |||
Official Title ICMJE | Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Japanese Male Subjects | |||
Brief Summary | The purpose of this study is to evaluate the safety and tolerability of single doses of BLI-489 administered intravenously in healthy Japanese male subjects, and how the drug is absorbed and eliminated. | |||
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 (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 40 | |||
Original Estimated Enrollment ICMJE | 56 | |||
Actual Study Completion Date ICMJE | April 27, 2009 | |||
Actual Primary Completion Date | April 1, 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | NCT00854009 | |||
Other Study ID Numbers ICMJE | 3219K1-1004 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | September 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |