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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nilotinib

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

Interventions

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Nilotinib

Intervention Type DRUG

Other Intervention Names

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AMN107

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes