- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00385489
Study Evaluating LXR-623 in Healthy Japanese Adults
August 6, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LXR-623 Administered Orally to Healthy Japanese Male Subjects.
The purpose of this study is to evaluate the safety of LXR-623 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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Toshima-ku, Tokyo, Japan, 171-0014
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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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy, Japanese Males aged 20-45 years
Exclusion Criteria:
- A history or active presence of clinically important medical disease
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: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety
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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
August 1, 2006
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
October 5, 2006
First Submitted That Met QC Criteria
October 6, 2006
First Posted (Estimate)
October 9, 2006
Study Record Updates
Last Update Posted (Estimate)
August 7, 2009
Last Update Submitted That Met QC Criteria
August 6, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- 3201A1-102
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.