Study Evaluating FXR-450 in Healthy Japanese Men | NCT00509756

Studies
Study Evaluating FXR-450 in Healthy Japanese Men

NCT00509756

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Terminated

Last Update Posted

Oct 22, 2010Estimated

Enrollment

56Actual

Phase

Phase 1

Conditions

Healthy

Interventions

FXR-450
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Please see termination statement in the detailed description.

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Jul 30, 2007

First Submission Date that Met QC Criteria

Jul 30, 2007

First Posted Date

Jul 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2010

Last Update Posted Date

Oct 22, 2010Estimated

Description Module

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.

Detailed Description

This study was terminated on May 2008. The reason for termination was due to pharmacokinetics issues. The decision to terminate was not due to safety and tolerability.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Drug: FXR-450	Drug: FXR-450
2	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FXR-450	Drug	capsule, single oral doses from 10 mg to 450 mg	1
Placebo

Measure	Description	Time Frame
The primary outcome is safety and tolerability.		4 days

Measure	Description	Time Frame
Pharmacokinetics		4 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Tokyo	Tokyo	171-0014	Japan

Intervention Browse Module

MeSH Terms

ID	Term
C540004	WAY-362450

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided