- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00434785
A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males
December 3, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
An Ascending, Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Healthy Male Japanese Subjects.
To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo
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Ikebukuro, Tokyo, Japan, 1520003
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after test article administration.
- Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight >45 kg.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead ECG.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To assess the safety and PK profile
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
February 9, 2007
First Submitted That Met QC Criteria
February 12, 2007
First Posted (Estimate)
February 13, 2007
Study Record Updates
Last Update Posted (Estimate)
December 5, 2007
Last Update Submitted That Met QC Criteria
December 3, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- 3189A1-105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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