HealthyPhase 1NCT00418626

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

A Phase 1 study testing Nilotinib in people with Healthy, run by Novartis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Nilotinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Nov 2006to Sep 2007
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Richmond, Virginia, 23249

Other trials in United States

About this study

Official title: 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

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

Conditions: Healthy
Being tested: Nilotinib
Keywords: nilotinib, hepatic impairment, Child-Pugh scale, PK, healthy, subject(s), Subjects with impaired hepatic function and healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NilotinibDrug
Also called AMN107

Study groups in NCT00418626
Study group	Role	What they receive
Nilotinib	Experimental	Not described Receives: Drug: Nilotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics of nilotinib

Secondary outcomes (1)

impact on hepatic function assessed by laboratory values and an electrocardiogram

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Sep 2007

First posted5 Jan 2007 (estimated)
Study startNov 2006
Primary completionSep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00418626
Sponsor's protocol ID: CAMN107A2116
Status last verified: Mar 2012
First submitted: 3 Jan 2007
Last updated: 8 Mar 2012
Results posted: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00418626
Acronym / sponsor ID: CAMN107A2116
Conditions: Healthy
Keywords: nilotinib, hepatic impairment, Child-Pugh scale, PK, healthy, subject(s), Subjects with impaired hepatic function and healthy subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Sep 2007 (actual)
First posted: 5 Jan 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nilotinib	Experimental	Drug: Nilotinib

Who may qualify

Ages: 18 to 70 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NilotinibAlso: AMN107	Drug	Nilotinib

Primary outcome

Pharmacokinetics of nilotinib

1 secondary outcome

impact on hepatic function assessed by laboratory values and an electrocardiogram

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
Derived from this study: PubMed 20110053Yin 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis study chair

Novartis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nilotinib in people with Healthy, run by Novartis Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics of nilotinib. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00418626, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2012.