CClinicalTrials.gg
Sign In
CompletedNCT00418626Updated Mar 8, 2012

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

A Phase 1 interventional study of Nilotinib in Healthy, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-08.

Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • nilotinib
  • hepatic impairment
  • Child-Pugh scale
  • PK
  • healthy, subject(s)
  • Subjects with impaired hepatic function and healthy subjects
03

In context

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts 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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Nilotinib

    Drug: Nilotinib

Interventions

  • DrugNilotinib

    Also known as: AMN107

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics of nilotinib

Secondary outcomes

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

07

Study locations

1 site
  • Richmond, Virginia 23249, United States
08

References and documents

Publications

  • 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. PubMed 20110053 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00418626
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 5, 2007
Start date
Nov 2006
Primary completion
Sep 2007
Last update
Mar 8, 2012

Study contacts

Novartis
study chair · Novartis
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Novartis Pharmaceuticals

Start the discussion