Pharmacokinetics of Nilotinib in Subjects With Impaired H... | NCT00418626

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

NCT00418626

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Mar 8, 2012Estimated

Enrollment

27Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Nilotinib

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Sep 2007Actual

Completion Date

Not provided

First Submitted Date

Jan 3, 2007

First Submission Date that Met QC Criteria

Jan 4, 2007

First Posted Date

Jan 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2012

Last Update Posted Date

Mar 8, 2012Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Label	Type	Description	Intervention Names
Nilotinib	Experimental		Drug: Nilotinib

Name	Type	Description	Arm Group Labels	Other Names
Nilotinib	Drug		Nilotinib	AMN107

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of nilotinib

Secondary Outcomes

Measure	Description	Time Frame
impact on hepatic function assessed by laboratory values and an electrocardiogram

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis	Novartis	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
		Richmond	Virginia	23249	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20110053	Derived	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.