Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

A Phase I, Single Center, Open-label, Single Oral Dose, Study to Assess the Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib

Inclusion Criteria:

1. Healthy adult male (18 -70 yrs)
2. Body weight must be ≥ 50 kg and < 120 kg, with a body mass index (BMI) >18 but < 35.
3. Laboratory parameters values within the normal range

Exclusion Criteria:

1. Contraindication or hypersensitivity to receiving nilotinib
2. Smokers or those who use of tobacco products or products containing nicotine
3. A past medical history of clinically significant Electrocardiogram abnormalities or a history/family history of long QT-interval syndrome.
4. History of fainting spells.

Other protocol-defined inclusion/exclusion criteria may apply.