- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00379860
Study Evaluation LXR-623 in Healthy Adults
March 8, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of LXR-623 Administered Orally to Healthy Subjects
To evaluate the safety and tolerability of multiple doses of LXR in healthy adults.
Study Overview
Study Type
Interventional
Phase
- Phase 1
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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Generally healthy adults.
- Liver function tests, triglycerideres, and creatinine must be below upper limit of normal at screening.
Exclusion Criteria:
- A history or active presence of clinically important medical disease.
- Any metal implants or devices.
- Claustrophobia.
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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Safety is the primary outcome.
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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
October 1, 2006
Study Completion
January 1, 2007
Study Registration Dates
First Submitted
September 21, 2006
First Submitted That Met QC Criteria
September 21, 2006
First Posted (Estimate)
September 25, 2006
Study Record Updates
Last Update Posted (Estimate)
March 9, 2007
Last Update Submitted That Met QC Criteria
March 8, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- 3201A1-101
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.