Study Evaluating Single Doses of ILV-095 in Healthy Japanese Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00822484
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : May 6, 2011
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy Japanese male subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Biological: ILV-095 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Japanese Male Subjects
Study Start Date : February 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Active Comparator: ILV-095
6 SC single dose injections
Biological: ILV-095
Placebo Comparator: Placebo
Other: Placebo

Primary Outcome Measures :
  1. Safety and tolerability will be evaluated from the reported AEs including any injection-site reactions, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results. [ Time Frame: 3 weeks per group ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: 3 weeks per group ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men aged 20 to 45 years inclusive at screening. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after study drug administration.
  • Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg.
  • Healthy as determined by the investigator on the basis of screening evaluations.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
  • Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any subject who had orthopedic surgery within 12 weeks of the screening visit or has planned (elective) orthopedic surgery within 12 weeks of study drug administration.
  • Acute disease state (eg, nausea, vomiting, infection, fever, active infection, or diarrhea) within 7 days before enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00822484

Pfizer Investigational Site
Tokyo, Japan
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00822484     History of Changes
Other Study ID Numbers: 3226K2-1001
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: May 6, 2011
Last Verified: May 2011