NCT02474537

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

Completed Phase 1 Last updated 10 December 2020

What this trial tests

Phase 1 trial testing INC280 in Hepatic Impairment in 31 participants. Completed in 12 September 2017.

Timeline

12 June 2015

Primary endpoint
14 August 2017

12 September 2017

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	12 June 2015
Primary completion	14 August 2017
Estimated completion	12 September 2017
Sites	5 locations across United States

Drugs / interventions tested

• INC280 — full drug profile →

Conditions studied

• Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Reviewing the role of healthy volunteer studies in drug development.
   Karakunnel JJ, Bui N, Palaniappan L, Schmidt KT, et al · · 2018 · cited 33× · PMID 30509294 · DOI 10.1186/s12967-018-1710-5
2. Targets of immunotherapy for hepatocellular carcinoma: An update.
   Rai V, Mukherjee S. · · 2022 · cited 7× · PMID 35126844 · DOI 10.4254/wjh.v14.i1.140
3. Pharmacokinetics of capmatinib in participants with hepatic impairment: A phase 1, open-label, single-dose, parallel-group study.
   Chen X, Cui X, Pognan N, Quinlan M, et al · · 2022 · cited 7× · PMID 34046915 · DOI 10.1111/bcp.14929