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Hepatic ImpairmentPhase 1NCT02474537

INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function

A Phase 1 study testing INC280 in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 5 sites in United States.

Completed

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

Official record
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Trial summary

This is a phase I, multi-center, open-label, single oral dose, parallel group study to evaluate the pharmacokinetics and safety of INC280 in non-cancer subjects with impaired hepatic function and non-cancer subjects with normal hepatic function.The study population will be healthy male and postmenopausal or sterile… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment
What is being tested?
INC280
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
5 sitesUnited States
Study dates
12 Jun 2015to 12 Sep 2017
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female subjects must be postmenopausal or sterile
  • Good health, as determined by absence of clinically significant findings in medical history, physical examination, vital signs, and ECGs, unless it is consistent with known clinical disease for hepatic impairment subjects
  • Adequate organ function and normal laboratory tests, unless it is consistent with known clinical disease for hepatic impairment subjects
  • Body Mass Index (BMI) of 18- 36 kg/m2, with body weight ≥ 50 kg
  • Confirmed liver disease
  • Stable comorbidities are allowed as long as generally considered healthy
Show all 12Show fewer
  • Subjects with hepatic impairment must meet the following laboratory values:
  • Aspartate transaminase (AST) ≤ 5 x ULN
  • Alanine transaminase (ALT) ≤ 5 x ULN
  • Total bilirubin ≤ 3 x ULN (≤ 5 x XULN for subjects with severe hepatic impairment [group 4])
  • Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 mL/min
  • Platelets > 50 x 10^9/L. Subjects with severe hepatic impairment can be enrolled if platelet count > 40 x 10^9/L

Who cannot join

  • History or presence of clinically significant ECG abnormalities or clinically significant cardiovascular disease
  • Immunocompromised subjects, including HIV
  • Use of drugs known to affect CYP3A4
  • Use of QT-prolonging drugs
  • Use of any other drugs, unless they are required to treat the hepatic impairment subject's disease
  • Use of proton pump inhibitors (PPI) medications within 7 days prior to dosing and during the current study until last day of confinement
Show all 11Show fewer
  • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
  • Active Grade 3 or 4 hepatic encephalopathy within 4 weeks of study entry
  • Clinical evidence of severe ascites
  • Ascites requiring paracentesis within 3 weeks prior to dosing
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Duke University Medical Center Oncology

    Durham, North Carolina, 27710

  • University of Miami Miller School of Medicine Clinical Resea Oncology

    Miami, Florida, 33136

  • Clinical Pharmacology of Miami, LLC.

    Miami, Florida, 33142

  • DaVita Clinical Research

    Minneapolis, Minnesota, 55404

  • Orlando Clinical Research Center

    Orlando, Florida, 32086

Other trials in United States

About this study

Official title: An Open Label, Single-dose, Multi-center, Parallel-group, Two-staged Study to Evaluate Pharmacokinetics of Oral cMET Inhibitor INC280 in Non-Cancer Subjects With Impaired Hepatic Function and Non-Cancer Subjects With Normal Hepatic Function

This is a phase I, multi-center, open-label, single oral dose, parallel group study to evaluate the pharmacokinetics and safety of INC280 in non-cancer subjects with impaired hepatic function and non-cancer subjects with normal hepatic function.The study population will be healthy male and postmenopausal or sterile female subjects who meet all of the inclusion and none of the exclusion criteria. Subjects will be assigned to groups according to their hepatic function: normal (Group 1), mild (Group 2), moderate (Group 3), and severe (Group 4) impairment. This study consists of a two-staged design with interim analysis. In Stage 1, subjects in Groups 1, 2 and 3 will be enrolled. Upon completion of Stage 1, an interim analysis will be conducted. Depending on the results of the analysis, either the study will conclude with no further enrollment or Stage 2 will commence with enrollment of Group 4.

A minimum of 6 evaluable subjects per group will be enrolled.Once enrolled in the study, participants will be confined to the facility for 4 days, given a single dose of INC280 and monitored for pharmacokinetic and safety assessments.

Being tested
INC280
Keywords
hepatic impairment,, INC280,, Oral cMET Inhibitor,, Non-Cancer

What participants receive

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

  • INC280Drug

    Single 200 mg dose INC280

Study groups in NCT02474537
Study groupRoleWhat they receive
Normal hepatic functionExperimentalSubjects with normal hepatic function
Receives: Drug: INC280
Mild hepatic impairmentExperimentalSubjects with mild hepatic impairment
Receives: Drug: INC280
Moderate hepatic impairmentExperimentalSubjects with moderate hepatic impairment
Receives: Drug: INC280
Severe hepatic impairmentExperimentalSubjects with severe hepatic impairment
Receives: Drug: INC280

What is being measured

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

  1. AUClast of INC280

    INC280 pharmacokinetic parameters

    Measured: Up to 72 hours post-dose

  2. AUCinf of INC280

    INC280 pharmacokinetic parameters

    Measured: Up to 72 hours post-dose

  3. Cmax of INC280

    INC280 pharmacokinetic parameters

    Measured: Up to 72 hours post-dose

  4. Tmax of INC280

    INC280 pharmacokinetic parameters

    Measured: Up to 72 hours post-dose

  5. T1/2 of INC280

    INC280 pharmacokinetic parameters

    Measured: Up to 72 hours post-dose

  6. CL/F of INC280

    INC280 pharmacokinetic parameters

    Measured: Up to 72 hours post-dose

  7. Vz/F of INC280

    INC280 pharmacokinetic parameters

    Measured: Up to 72 hours post-dose

Secondary outcomes (8)

  1. Adverse events based on the CTCAE v4.03 grade (severity) and frequency, and other safety data (e.g., ECG, laboratory results)

    Safety

    Measured: Up to 30 days

  2. Unbound fraction and AUClast based on unbound concentration in plasma

    To assess the plasma protein binding of INC280

    Measured: 3 hours post-dose

  3. Unbound fraction and AUCinf based on unbound concentration in plasma

    To assess the plasma protein binding of INC280

    Measured: 3 hours post-dose

  4. Unbound fraction and Cmax based on unbound concentration in plasma

    To assess the plasma protein binding of INC280

    Measured: 3 hours post-dose

  5. Unbound fraction and Tmax based on unbound concentration in plasma

    To assess the plasma protein binding of INC280

    Measured: 3 hours post-dose

  6. Unbound fraction and T1/2 based on unbound concentration in plasma

    To assess the plasma protein binding of INC280

    Measured: 3 hours post-dose

  7. Unbound fraction and CL/F based on unbound concentration in plasma

    To assess the plasma protein binding of INC280

    Measured: 3 hours post-dose

  8. Unbound fraction and Vz/F based on unbound concentration in plasma

    To assess the plasma protein binding of INC280

    Measured: 3 hours post-dose

Timeline

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

  1. First posted17 Jun 2015 (estimated)
  2. Study start12 Jun 2015
  3. Primary completion14 Aug 2017
  4. Study completion12 Sep 2017

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02474537
Sponsor's protocol ID
CINC280A2106
Status last verified
Mar 2019
First submitted
9 Jun 2015
Last updated
10 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen X, Cui X, Pognan N, Quinlan M, Kapoor S, Rahmanzadeh G, Giovannini M, Marbury TC. Pharmacokinetics of capmatinib in participants with hepatic impairment: A phase 1, open-label, single-dose, parallel-group study. Br J Clin Pharmacol. 2022 Jan;88(1):91-102. doi: 10.1111/bcp.14929. Epub 2021 Jun 18.

    PubMed 34046915

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INC280 in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 5 sites 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 12 inclusion and 11 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

AUClast of INC280 (time frame: Up to 72 hours post-dose). The study lists 7 primary outcomes in all. 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 NCT02474537, 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 10 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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