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

March 7, 2012 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nilotinib
Drug: Nilotinib
Other Names:
  • AMN107

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetics of nilotinib

Secondary Outcome Measures

Outcome Measure
impact on hepatic function assessed by laboratory values and an electrocardiogram

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 5, 2007

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAMN107A2116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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