Current Study: E 1

Purpose:
• To determine how the investigational drug is absorbed, broken down, and removed from the body in volunteers with kidney impairment on dialysis when compared to volunteers with a normal level of kidney function.
• Information regarding safety and side effects that may occur will also be collected.
• This study is for research purposes only and is not intended to treat your kidney disease.

Method of Administration:  Single oral dose of study drug given on 2 separate periods

Investigator: Thomas Marbury, MD

To qualify:

• 18 to 80 years old
• Must have kidney impairment or disease and receive dialysis treatments
• May be seeing a nephrologist, have reduced kidney function, or low creatinine clearance and taking medicine such as:

• Procrit®, Epogen®, or Aranesp® for low blood count
or
• PhosLo for high blood phosphorus

Length/Duration:

• 6 days and 5 nights in our research facility and 7 follow-up visits
• 2 separate occasions

Location: 5055 South Orange Avenue, Orlando, FL 32809

Compensation: Qualified participants will receive study medication, study related physical exams and laboratory tests

Qualified participants may be compensated up to $5,800 for time and travel

Whom to Contact:  Recruitment Department: 407-240-7876