Study Evaluating the Safety of FXR-450 in Healthy Subjects - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: FXR 450 Drug: placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title:	Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety, tolerability [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

pharmacokinetics [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	October 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Arm 1: FXR 450	Drug: FXR 450 capsule, single oral doses from 10 mg to 450 mg
2: Placebo Comparator Placebo	Drug: placebo capsule similar to active drug

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499629

Locations


United States, Pennsylvania
	Facility
	Philadelphia, Pennsylvania, United States, 19148

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3213A1-1000
First Received:	July 9, 2007
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00499629
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

healthy subjects

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00499629