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Study Evaluating the Safety of FXR-450 in Healthy Subjects

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Facility
Philadelphia, Pennsylvania, 19148 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00499629
Pfizer
Completed
Study Evaluating the Safety of FXR-450 in Healthy Subjects

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Study Evaluating the Safety of FXR-450 in Healthy Subjects
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Healthy
  • Drug: FXR 450
    capsule, single oral doses from 10 mg to 450 mg
  • Drug: placebo
    capsule similar to active drug
  • Active Comparator: 1
    Arm 1: FXR 450
    Intervention: Drug: FXR 450
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
February 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00499629
3213A1-1000
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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