Study Evaluating FXR-450 in Healthy Japanese Men
Overview
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.
Full Title of Study: “Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Japanese Male Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: February 2008
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.
Interventions
- Drug: FXR-450
- capsule, single oral doses from 10 mg to 450 mg
- Drug: Placebo
- capsule similar to active drug
Arms, Groups and Cohorts
- Active Comparator: 1
- Drug: FXR-450
- Placebo Comparator: 2
- Placebo
Clinical Trial Outcome Measures
Primary Measures
- The primary outcome is safety and tolerability.
- Time Frame: 4 days
Secondary Measures
- Pharmacokinetics
- Time Frame: 4 days
Participating in This Clinical Trial
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).
Gender Eligibility: Male
Minimum Age: 20 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Provider of Information About this Clinical Study
- Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
- Overall Official(s)
- Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
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