NCT00509756

Brief Summary

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single dose of FXR-450 in healthy Japanese men.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
terminated

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 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
3 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

October 22, 2010

Status Verified

October 1, 2010

Enrollment Period

3 months

First QC Date

July 30, 2007

Last Update Submit

October 21, 2010

Conditions

Healthy

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is safety and tolerability.

    4 days

Secondary Outcomes (1)

  • Pharmacokinetics

    4 days

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: 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

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 20 to 45 years.
  • Healthy as determined by the investigator.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day.

You may not qualify if:

  • A history or active presence of clinically important medical disease.
  • Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (e.g., resection of liver, kidney, gallbladder, or gastrointestinal tract).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Tokyo, 171-0014, Japan

Location

MeSH Terms

Interventions

WAY-362450

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 30, 2007

First Posted

July 31, 2007

Study Start

November 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

October 22, 2010

Record last verified: 2010-10

Locations

JP(1)