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

Novartis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Nilotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418626

CAMN107A2116

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Nilotinib

Experimental group

Treatment:

Drug: Nilotinib