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Study Evaluating the Safety of FXR-450 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00499629
Recruitment Status : Completed
First Posted : July 11, 2007
Last Update Posted : March 13, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: FXR 450 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Subjects
Study Start Date : October 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Arm Intervention/treatment
Active Comparator: 1
Arm 1: FXR 450
Drug: FXR 450
capsule, single oral doses from 10 mg to 450 mg
Placebo Comparator: 2
Drug: placebo
capsule similar to active drug

Primary Outcome Measures :
  1. Safety, tolerability [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. pharmacokinetics [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499629

United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00499629     History of Changes
Other Study ID Numbers: 3213A1-1000
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008

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