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Completed

NCT Number: NCT00499629

Study Evaluating the Safety of FXR-450 in Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Facility

Philadelphia, Pennsylvania, 19148, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FXR 450

Drug

capsule, single oral doses from 10 mg to 450 mg

Placebo

Drug

capsule similar to active drug

Primary outcomes

  1. Safety, tolerability

    Time frame: 4 days

Secondary outcomes

  1. pharmacokinetics

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 11, 2007
Registry last updated
Mar 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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