Study Evaluating the Safety of FXR-450 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: placebo; Drug: FXR 450

• Registration Number: NCT00499629
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Study Start: 2007-10
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-12
• Last Update Posted: 2008-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	Placebo
1	FXR 450	Arm 1: FXR 450

Primary Outcome Measures

Name	Time	Method
Safety, tolerability	4 days

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics	4 days

Trial Locations

Locations (1)

Facility; 🇺🇸 Philadelphia, Pennsylvania, United States