Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects

An Open Label, Non-randomised, Parallel Group Study to Characterise and Compare the Pharmacokinetics, Safety and Tolerability of a Single Dose of AGO178C in Subjects With Mild, Moderate, Severe Renal Impairment and End-stage Renal Disease With That in Healthy Matched Control Subjects

This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healthy matched control subjects.

Inclusion Criteria:

• Mild, moderate, severe renally impaired or ESRD patients.
• Healthy male or female subjects to match renally impaired patients in BMI (±15%), age (± 7 years) and gender (in this order). Smoking status (yes or no) will also be used as a final criterion, if deemed feasible by the Investigator.

Exclusion Criteria:

• Pregnant or nursing (lactating) women
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study as defined in the protocol.
• Smokers, smoking 10 cigarettes or more per day from screening to study completion
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
• Co-medication for healthy subjects

Other protocol-defined inclusion/exclusion criteria may apply