NCT00418626

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

January 3, 2007

Last Update Submit

March 7, 2012

Conditions

Healthy

Keywords

nilotinibhepatic impairmentChild-Pugh scalePKhealthy, subject(s)Subjects with impaired hepatic function and healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of nilotinib

Secondary Outcomes (1)

  • impact on hepatic function assessed by laboratory values and an electrocardiogram

Study Arms (1)

Nilotinib

EXPERIMENTAL
Drug: Nilotinib

Interventions

NilotinibDRUG
Also known as: AMN107
Nilotinib

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Richmond, Virginia, 23249, United States

Location

Related Publications (1)

  • Yin OQ, Gallagher N, Tanaka C, Fisher D, Sethuraman V, Zhou W, Lin TH, Heuman D, Schran H. Effects of hepatic impairment on the pharmacokinetics of nilotinib: an open-label, single-dose, parallel-group study. Clin Ther. 2009;31 Pt 2:2459-69. doi: 10.1016/j.clinthera.2009.11.015.

    PMID: 20110053DERIVED

MeSH Terms

Interventions

nilotinib

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 5, 2007

Study Start

November 1, 2006

Primary Completion

September 1, 2007

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(1)