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OpenTrials
Completed

NCT Number: NCT00418626

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

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Richmond, Virginia, 23249, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult male (18 -70 yrs)
  • Body weight must be ≥ 50 kg and < 120 kg, with a body mass index (BMI) >18 but < 35.
  • Laboratory parameters values within the normal range

Exclusion criteria

  • Contraindication or hypersensitivity to receiving nilotinib
  • Smokers or those who use of tobacco products or products containing nicotine
  • A past medical history of clinically significant Electrocardiogram abnormalities or a history/family history of long QT-interval syndrome.
  • History of fainting spells.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Nilotinib

Drug

Other names: AMN107

Primary outcomes

  1. Pharmacokinetics of nilotinib

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
First posted
Jan 5, 2007
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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