Study Evaluating FXR-450 in Healthy Japanese Men

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00509756
• Other study ID #: 3213A1-1002
• Status: Terminated
• Phase: Phase 1
• First received: July 30, 2007
• Last updated: October 21, 2010
• Start date: November 2007
• Est. completion date: February 2008

Study information

• Verified date: October 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• FXR-450
capsule, single oral doses from 10 mg to 450 mg
• Placebo
capsule similar to active drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is safety and tolerability.		4 days	Yes
Secondary	Pharmacokinetics		4 days	No