Trial record 1 of 1 for: NCT00366522

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Study Evaluating LXR-623 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00366522

Recruitment Status : Completed

First Posted : August 21, 2006

Last Update Posted : August 7, 2009

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

First Submitted Date ^ICMJE

August 17, 2006

First Posted Date ^ICMJE

August 21, 2006

Last Update Posted Date

August 7, 2009

Study Start Date ^ICMJE

August 2006

Actual Primary Completion Date

September 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and Tolerability

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 Evaluating LXR-623 in Healthy Subjects

Official Title ^ICMJE

Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LXR-623 Administered Orally to Healthy Subjects

Brief Summary

To evaluate the safety and tolerability of a single dose of LXR-623 in healthy 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:

Healthy, men or women, aged 19-50 years

Exlcusion:

Use of any investigational or prescription drug within 30 days before study start
Any clinically imprtant medical disease or abnormal laboratory test results

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

19 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

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00366522

Other Study ID Numbers ^ICMJE

3201A1-100

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

August 2009

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

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