Current Study: M 20

Purpose:

• To determine how the investigational drug is absorbed, broken down, and removed from the body in volunteers with kidney impairment on hemodialysis 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 on 2 separate occasions

Investigator: Thomas Marbury, MD

To qualify:

• 18 to 75 years old
• Women that are postmenopausal or have had a hysterectomy or men who’ve had a vasectomy
• Must have kidney impairment or disease and receiving hemodialysis treatment 3 times per week
• 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:

• 5 days and 4 nights in our research facility, on two separate occasions
• 1 follow-up visit

Location: 5055 South Orange Avenue, Orlando, FL 32809

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

Qualified participants will be compensated up to $3,225 for time and travel related expenses

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