Trials / Terminated
TerminatedNCT00509756
Study Evaluating FXR-450 in Healthy Japanese Men
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Japanese Male Subjects
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- Male
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FXR-450 | capsule, single oral doses from 10 mg to 450 mg |
| DRUG | Placebo | capsule similar to active drug |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2007-07-31
- Last updated
- 2010-10-22
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00509756. Inclusion in this directory is not an endorsement.