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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00822484
First received: January 13, 2009
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Biological: ILV-095
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: 3 weeks per group ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: February 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ILV-095
6 SC single dose injections
Biological: ILV-095
Placebo Comparator: Placebo
Placebo
Other: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822484

Locations
Japan
Pfizer Investigational Site
Tokyo, Japan
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00822484     History of Changes
Other Study ID Numbers: 3226K2-1001
Study First Received: January 13, 2009
Last Updated: May 4, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on April 17, 2014