Hepatic Impairment
Conditions
Keywords
AFQ056, Hepatic impairment, Hepatic impaired
Brief summary
This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.
Interventions
DRUGAFQ056
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Groups 1, 2, 3 and 4 (all subjects) * Male and female Caucasian subjects * Group 1, 2 and 3 (subjects with hepatic impairment) * Subjects must satisfy the criteria for hepatic impairment as evidenced by a Child-Pugh score of A, B or C at screening * Group 4 (healthy subjects) * Each healthy subject must match in age (±8 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1, 2 or 3.
Exclusion criteria
* Groups 1, 2, 3 and 4 (all subjects) * Use of any tobacco products from 1 week prior to cotinine screening assessments until study completion. * Group 1, 2 and 3 (subjects with hepatic impairment) * History of drug or alcohol abuse within 3 months prior to screening * History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases within 1 month prior to study drug administration except for hepatic impairment or any other disease associated with this underlying condition. * Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. * History or presence of encephalopathy within 6 months prior screening (except for subjects in Groups 2 and 3). * Documented presence of a porto-systemic shunt. * Documented presence of esophagus varices (stage III or IV). * Group 4 (healthy subjects) * History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases. * Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline. * History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose | AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure: : Number of subjects with adverse event in each group | From dose administration (day 1) to 13+/- 2 days after the single dose administration | Number and type of adverse events, number and type of findings in standard laboratory results, special laboratory results (Hypothaliamic-pituitary axis, porphyrin profile) electrocardiogram holters, or in vital signs |
| Measure: Plasma protein binding results of AFQ056 in each groups. | 2 hours after single dose administration | — |
Countries
Germany, Hungary, United States
Outcome results
None listed