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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00418626
First received: January 3, 2007
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Nilotinib
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pharmacokinetics of nilotinib

Secondary Outcome Measures:
  • impact on hepatic function assessed by laboratory values and an electrocardiogram

Enrollment: 27
Study Start Date: November 2006
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib
Other Name: AMN107

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418626

Locations
United States, Virginia
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00418626     History of Changes
Other Study ID Numbers: CAMN107A2116
Study First Received: January 3, 2007
Last Updated: March 7, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014