A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Inclusion Criteria:

All subjects:

- At least 50 kg and body mass index (BMI) within 18-38 kg/m2.

- CYP2C9 wild-type (CYP2C9*1 homozygous carriers)

Renal impairment:

- Subjects must have either mild, moderate or severe renal impairment

Exclusion Criteria:

All subjects

- Use of other investigational drugs within certain timelines

- Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to
initial dosing

- History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in
the 24-h Holter ECG recording including episodes of bradycardia (HR < 50 bpm) during
waking hours and/or arrhythmic episodes; subjects with history or presence of
ventricular rhythm disturbances (ventricular extra-systoles >100/24h, or higher
grade), or supraventricular arrhythmias (other than occasional supraventricular
ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with
conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.

- Women of child-bearing potential

- History of malignancy of any organ system

- History or presence of symptomatic postural hypotension or syncope.

- Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory
normal range or platelet count < 30,000/μL at screening or baseline.

- Clinically significant infection or recent vaccination with live-attenuated vaccines.

- History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen
(HBsAg) or Hepatitis C test result at screening.

Renal impairment:

- History or presence of any non-controlled and clinically significant disease that
could affect the study outcome or that would place the patient at undue risk.

- Any surgical or medical condition other than renal impairment which might
significantly alter the absorption, distribution, metabolism, or excretion of drugs,
or which may jeopardize the safety of the study subject in case of participation in
the study.

- Treatment with certain drugs

Healthy subjects:

- History or presence of any clinically significant disease of any major system organ
class including (but not limited to) cardiovascular, metabolic, renal, neurological or
psychiatric diseases.

- Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the
subject in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply