Status:
COMPLETED
Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Healthy
Eligibility:
MALE
18-70 years
Phase:
PHASE1
Brief Summary
This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib
Eligibility Criteria
Inclusion
- Healthy adult male (18 -70 yrs)
- Body weight must be ≥ 50 kg and \< 120 kg, with a body mass index (BMI) \>18 but \< 35.
- Laboratory parameters values within the normal range
Exclusion
- Contraindication or hypersensitivity to receiving nilotinib
- Smokers or those who use of tobacco products or products containing nicotine
- A past medical history of clinically significant Electrocardiogram abnormalities or a history/family history of long QT-interval syndrome.
- History of fainting spells.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00418626
Start Date
November 1 2006
Last Update
March 8 2012
Active Locations (1)
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1
Richmond, Virginia, United States, 23249