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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00418626
First Posted: January 5, 2007
Last Update Posted: March 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418626


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00418626     History of Changes
Other Study ID Numbers: CAMN107A2116
First Submitted: January 3, 2007
First Posted: January 5, 2007
Last Update Posted: March 8, 2012
Last Verified: March 2012

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