Study Evaluating LXR-623 in Healthy Japanese Adults

NCT00385489

Last updated date
Study Location
Toshima-ku, Tokyo, 171-0014, Japan
Contact
1-800-718-1021

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By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy, Japanese Males aged 20-45 years

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- A history or active presence of clinically important medical disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating LXR-623 in Healthy Japanese Adults
Official Title  ICMJE Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LXR-623 Administered Orally to Healthy Japanese Male Subjects.
Brief Summary The purpose of this study is to evaluate the safety of LXR-623 in healthy Japanese subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
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 Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy, Japanese Males aged 20-45 years

Exclusion Criteria:

  • A history or active presence of clinically important medical disease
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00385489
Other Study ID Numbers  ICMJE 3201A1-102
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 MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

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