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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Nilotinib

• Registration Number: NCT00418626
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Primary Completion: 2007-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nilotinib	Nilotinib	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of nilotinib

Secondary Outcome Measures

Name	Time	Method
impact on hepatic function assessed by laboratory values and an electrocardiogram