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
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 April 17, 2014