Clinical trial · Interventional
INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Impairment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INC280 | Drug | Capmatinib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Normal hepatic function
- description
- Subjects with normal hepatic function
- interventionNames
- Drug: INC280
- type
- EXPERIMENTAL
- label
- Mild hepatic impairment
- description
- Subjects with mild hepatic impairment
- interventionNames
- Drug: INC280
- type
- EXPERIMENTAL
- label
- Moderate hepatic impairment
- description
- Subjects with moderate hepatic impairment
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria (all groups): * 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 Inclusion Criteria (hepatic impairment groups): * Confirmed liver disease * Stable comorbidities are allowed as long as generally considered healthy * 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 Exclusion Criteria (all groups): * 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 Exclusion Criteria (normal hepatic function group): * A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result Exclusion Criteria (hepatic impairment groups): * 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.
References
Publications (1)
- DERIVEDChen 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. PMID 34046915