Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

Inclusion Criteria:

-Other then hepatic impairment, subjects should be in good health as determined by past
medical history, physical examination, vital signs, electrocardiogram (except for
additional inclusion criteria for hepatic impaired subjects). -Subjects must weigh at least
50 kg and no more than 120 kg and have a body mass index in the range 18.0-36.0 kg/m2.

Additional criteria for hepatic impaired subjects: -Subjects must have a score clinically
determined and calculated as per the Child-Pugh classification and consistent with the
degree of hepatic impairment in which study is currently enrolling. -Stable Child-Pugh
status within 28 days prior to dosing.

Exclusion Criteria: All subjects:

- Subject has received a liver transplant at any time in the past and is on
immunosuppressant therapy.

- Smokers not willing to limit the use of tobacco to 10 cigarettes per day. -Surgical or
medical condition which might significantly alter the absorption, distribution,
metabolism, or excretion of drugs, or which may jeopardize the subject's safety in
case of participation in the study. -Use of any herbal medications/supplements.

History of acute pancreatitis within 1 year of study entry.

Additional criteria for subjects with normal liver function:

-Use of any prescription or non-prescription medication. -Positive Hepatitis B surface
antigen (HBsAg) or Hepatitis C test result.

Additional criteria for hepatic impaired subjects: -Use of any prescription or
non-prescription medication, that has the potential to interact with alpelisb. Concomitant
medications without potential to interact with alpelisib must be stable in dose.
-Encephalopathy grade 3 or worse. -Total bilirubin > 6 mg/dl. Screening or baseline ECG:
QTcF>480msec for both genders

Other protocol-defined inclusion/exclusion criteria may apply.