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Clinical Trials/NCT02474537
NCT02474537
Completed
Phase 1

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

Novartis Pharmaceuticals5 sites in 1 country31 target enrollmentJune 12, 2015
InterventionsINC280
DrugsINC280

Overview

Phase
Phase 1
Intervention
INC280
Conditions
Hepatic Impairment
Sponsor
Novartis Pharmaceuticals
Enrollment
31
Locations
5
Primary Endpoint
AUClast of INC280
Status
Completed
Last Updated
5 years ago

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
June 12, 2015
End Date
September 12, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Normal hepatic function

Subjects with normal hepatic function

Intervention: INC280

Mild hepatic impairment

Subjects with mild hepatic impairment

Intervention: INC280

Moderate hepatic impairment

Subjects with moderate hepatic impairment

Intervention: INC280

Severe hepatic impairment

Subjects with severe hepatic impairment

Intervention: INC280

Outcomes

Primary Outcomes

AUClast of INC280

Time Frame: Up to 72 hours post-dose

INC280 pharmacokinetic parameters

AUCinf of INC280

Time Frame: Up to 72 hours post-dose

INC280 pharmacokinetic parameters

CL/F of INC280

Time Frame: Up to 72 hours post-dose

INC280 pharmacokinetic parameters

Vz/F of INC280

Time Frame: Up to 72 hours post-dose

INC280 pharmacokinetic parameters

Cmax of INC280

Time Frame: Up to 72 hours post-dose

INC280 pharmacokinetic parameters

Tmax of INC280

Time Frame: Up to 72 hours post-dose

INC280 pharmacokinetic parameters

T1/2 of INC280

Time Frame: Up to 72 hours post-dose

INC280 pharmacokinetic parameters

Secondary Outcomes

  • Unbound fraction and T1/2 based on unbound concentration in plasma(3 hours post-dose)
  • Unbound fraction and CL/F based on unbound concentration in plasma(3 hours post-dose)
  • Unbound fraction and Vz/F based on unbound concentration in plasma(3 hours post-dose)
  • Adverse events based on the CTCAE v4.03 grade (severity) and frequency, and other safety data (e.g., ECG, laboratory results)(Up to 30 days)
  • Unbound fraction and AUClast based on unbound concentration in plasma(3 hours post-dose)
  • Unbound fraction and AUCinf based on unbound concentration in plasma(3 hours post-dose)
  • Unbound fraction and Cmax based on unbound concentration in plasma(3 hours post-dose)
  • Unbound fraction and Tmax based on unbound concentration in plasma(3 hours post-dose)

Study Sites (5)

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