Prucalopride Subjects With Renal Impairment

Inclusion Criteria: All subjects had to meet the following inclusion criteria:

• Between the ages of 18 and 75 years, inclusive;

• Males or females. Females were to be of non-childbearing potential. Normal subjects had to meet the following additional inclusion criteria:

• Demographically comparable to the subjects with renal impairment, within 30% of meanweight and height and 10% of the mean age;

• Physical examination, clinical laboratory results, and 12-lead ECG within normallimits at screening;

• No intake of medication, including over-the-counter medication, during a pre-trial 7-day drug-free washout period; Subjects with renal impairment had to meet the following additional inclusion criteria:

• Stable severity of renal disease;

• Concomitant medications to treat underlying disease states or medical conditionsrelated to renal insufficiency were allowed;

• Stable dose of medication and/or treatment regimen from 2 months prior to and duringthe trial;

• Subjects with stable cardiovascular disease could be enrolled, provided that theinvestigator felt their condition would not interfere with the results of the trial.

Exclusion Criteria: All subjects who met any of the following criteria were excluded from the trial:

• History of hypersensitivity to prucalopride or inactive ingredients in theprucalopride capsule or to related prokinetic compounds;

• Use of any other investigational drug within 30 days prior to signing the consent orintention to take any investigational drug during the trial;

• History of significant blood loss, or blood plasma donation (500mL) within the last 30days;

• Pregnancy or breast feeding;

• Gastrointestinal (GI) surgery within 3 months, or history of major GI surgery withpotential compromise of drug absorption or metabolism; Normal subjects who met any of the following criteria were excluded from the trial:

• Any abnormal medical history, physical examination, ECG, or laboratory results;

• Use of medications 7 days prior to and during the trial.

• Subjects with renal impairment who met any of the following criteria were excludedfrom the trial.

• Any abnormality in medical history, physical examination, ECG, or laboratory resultsthat, in the opinion of the investigator, might affect the safety of the subject;

• History of uric acid stone disease, uricosuria, or gout, or current hyperuricemia;

• Renal transplants, lupus erythematosus, or renal carcinoma.