Study Evaluating Single Doses of ILV-095 in Healthy Japanese Male Subjects
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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 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 May 21, 2013