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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00418626
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Nilotinib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nilotinib	Drug: Nilotinib; Other Names: AMN107

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of nilotinib []

Secondary Outcome Measures

1. impact on hepatic function assessed by laboratory values and an electrocardiogram []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Richmond	Virginia	United States	23249

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Chair: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00418626
• Other Study ID Numbers: CAMN107A2116
• First Posted: Jan 5, 2007
• Last Update Posted: Mar 8, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Novartis Pharmaceuticals: nilotinib; hepatic impairment; Child-Pugh scale; PK; healthy, subject(s); Subjects with impaired hepatic function and healthy subjects

Study Results

No Results Posted as of Mar 8, 2012