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Trial record 1 of 1 for:    NCT00379860
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Study Evaluation LXR-623 in Healthy Adults

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ClinicalTrials.gov Identifier: NCT00379860
Recruitment Status : Terminated
First Posted : September 25, 2006
Last Update Posted : March 9, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE September 21, 2006
First Posted Date  ICMJE September 25, 2006
Last Update Posted Date March 9, 2007
Study Start Date  ICMJE October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September¬†21,¬†2006)
Safety is the primary outcome.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluation LXR-623 in Healthy Adults
Official Title  ICMJE A Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of LXR-623 Administered Orally to Healthy Subjects
Brief Summary To evaluate the safety and tolerability of multiple doses of LXR in healthy adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE Drug: LXR-623
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00379860
Other Study ID Numbers  ICMJE 3201A1-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP