Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects
NCT00434746
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- Men aged 20 to 45 years inclusive at screening.
- Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight>45.
- Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking during inpatient stay.
- Healthy as determined by the investigator on the basis of screening evaluation.
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Descriptive Information | ||||
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Brief Title ICMJE | Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects | |||
Official Title ICMJE | Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-094 Administered IV and One Dose of SC Administered to Healthy Subjects | |||
Brief Summary | The purpose of this study is to assess the safety and tolerability of ascending single IV doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects. | |||
Detailed Description | This is a randomized, double-blind, placebo-controlled, inpatient/outpatient, sequential-group study of ascending single IV doses of ILV-094 administered to healthy Japanese male subjects. | |||
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 | Drug: ILV-094
Single, ascending doses of 5, 15, 50, 100, 300, and 600 mg IV or SC dose of ILV-094 or placebo | |||
Study Arms ICMJE | Not Provided | |||
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 | |||
Estimated Enrollment ICMJE | 56 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | February 2008 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 40 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 | NCT00434746 | |||
Other Study ID Numbers ICMJE | 3199K1-1102 | |||
Has Data Monitoring Committee | Not Provided | |||
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 |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | July 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |