Study Evaluating the Safety of FXR-450 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00499629
First received: July 9, 2007
Last updated: March 12, 2008
Last verified: March 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 is now a wholly owned subsidiary of Pfizer:

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
Active Comparator: 1
Arm 1: FXR 450
Drug: FXR 450
capsule, single oral doses from 10 mg to 450 mg
Placebo Comparator: 2
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 is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy subjects

ClinicalTrials.gov processed this record on April 17, 2014