NCT00499629

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

March 13, 2008

Status Verified

March 1, 2008

Enrollment Period

4 months

First QC Date

July 9, 2007

Last Update Submit

March 12, 2008

Conditions

Healthy

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Safety, tolerability

    4 days

Secondary Outcomes (1)

  • pharmacokinetics

    4 days

Study Arms (2)

1

ACTIVE COMPARATOR

Arm 1: FXR 450

Drug: FXR 450

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

FXR 450DRUG

capsule, single oral doses from 10 mg to 450 mg

1
placeboDRUG

capsule similar to active drug

2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facility

Philadelphia, Pennsylvania, 19148, United States

Location

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 11, 2007

Study Start

October 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

March 13, 2008

Record last verified: 2008-03

Locations

US(1)