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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00418626

Enrollment

Registered

2007-01-05

Start date

2006-11-30

Completion date

Unknown

Last updated

2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

nilotinib, hepatic impairment, Child-Pugh scale, PK, healthy, subject(s), Subjects with impaired hepatic function and healthy subjects

Brief summary

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

Interventions

DRUGNilotinib

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of nilotinib	—

Secondary

Measure	Time frame
impact on hepatic function assessed by laboratory values and an electrocardiogram	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026