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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.