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

This study is ongoing, but not recruiting participants.

First Received: January 13, 2009 Last Updated: July 17, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00822484

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Pharmacokinetics/Dynamics Study
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:

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 ]

Estimated Enrollment:	48
Study Start Date:	February 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ILV-095: Active Comparator 6 SC single dose injections	Biological: ILV-095
Placebo: Placebo Comparator Placebo	Other: Placebo

Eligibility

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

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3226K2-1001
Study First Received:	January 13, 2009
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00822484 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 01, 2009