Study Evaluating the Safety of FXR-450 in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The primary purpose of the study is to evaluate the safety of FXR-450 in healthy subjects. This study will also evaluate pharmacokinetics (PK) of FXR-450 in healthy subjects.

Key facts

Study ID

NCT00499629

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

64

Starts

2007-10-01

Expected to finish

2008-02-01

Last updated by the study team

2008-03-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
• Healthy as determined by the investigator on the basis of screening evaluations.
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

You may not qualify if…

• Any significant medical disease.
• History of cholecystectomy (removal of gallbladder).
• Any clinically important finding in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.

Where it is running

• Facility — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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