INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
- Conditions
- Hepatic Impairment
- Interventions
- Drug: INC280
- Registration Number
- NCT02474537
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mild hepatic impairment INC280 Subjects with mild hepatic impairment Moderate hepatic impairment INC280 Subjects with moderate hepatic impairment Normal hepatic function INC280 Subjects with normal hepatic function Severe hepatic impairment INC280 Subjects with severe hepatic impairment
- Primary Outcome Measures
Name Time Method AUClast of INC280 Up to 72 hours post-dose INC280 pharmacokinetic parameters
AUCinf of INC280 Up to 72 hours post-dose INC280 pharmacokinetic parameters
Cmax of INC280 Up to 72 hours post-dose INC280 pharmacokinetic parameters
Tmax of INC280 Up to 72 hours post-dose INC280 pharmacokinetic parameters
T1/2 of INC280 Up to 72 hours post-dose INC280 pharmacokinetic parameters
CL/F of INC280 Up to 72 hours post-dose INC280 pharmacokinetic parameters
Vz/F of INC280 Up to 72 hours post-dose INC280 pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method Unbound fraction and T1/2 based on unbound concentration in plasma 3 hours post-dose To assess the plasma protein binding of INC280
Unbound fraction and CL/F based on unbound concentration in plasma 3 hours post-dose To assess the plasma protein binding of INC280
Unbound fraction and Vz/F based on unbound concentration in plasma 3 hours post-dose To assess the plasma protein binding of INC280
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 Safety
Unbound fraction and AUClast based on unbound concentration in plasma 3 hours post-dose To assess the plasma protein binding of INC280
Unbound fraction and AUCinf based on unbound concentration in plasma 3 hours post-dose To assess the plasma protein binding of INC280
Unbound fraction and Cmax based on unbound concentration in plasma 3 hours post-dose To assess the plasma protein binding of INC280
Unbound fraction and Tmax based on unbound concentration in plasma 3 hours post-dose To assess the plasma protein binding of INC280
Trial Locations
- Locations (5)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Clinical Pharmacology of Miami, LLC.
🇺🇸Miami, Florida, United States
DaVita Clinical Research
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center Oncology
🇺🇸Durham, North Carolina, United States
University of Miami Miller School of Medicine Clinical Resea Oncology
🇺🇸Miami, Florida, United States