Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment

Inclusion criteria (for all subjects) * Male and/or female subjects 18-75 years of age * Females must be of non-childbearing potential . All non-postmenopausal females must have a confirmed negative serum pregnancy * Subjects in good health condition as determined by no clinically significant findings from medical history and physical examination. * Body mass index (BMI) between ≥18.0 and ≤38.0 kg/m2, with body weight ≥ 50 kg and no more than 140 kg * Laboratory values must be within normal limits (correction allowed) or considered clinically insignificant * Do not participate in any other clinical trials with a BRAF or other RAF inhibitors Additional inclusion criteria for patients with normal hepatic function (Control group): * Absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms and clinical laboratory determinations. * Must match to at least one hepatic impairment subject by age, gender and bodyweight Additional inclusion criteria for hepatic impaired subjects: * Confirmed hepatic disease * Stable Child-Pugh status within 28 days prior to dosing. Exclusion criteria for all subjects * Participation in any clinical investigation within 4 weeks prior to dosing * Significant acute illness within the two weeks prior to dosing * History of immunodeficiency diseases, including a positive HIV * History of malignancy of any organ system, treated or untreated, within 5 years * Any prior history of keratoacanthoma and/or cutaneous squamous cell carcinoma * A known diagnosis of any of the RASopathies, such as NF-1, Noonan syndrome, or related conditions. * History of drug or alcohol abuse within the 6 months prior to dosing * Smoking: urine cotinine levels below 500 ng/mL on Day -1. * Use of drugs known to affect CYP3A4 and/or CYP2C8 including both (strong or moderate) inhibitors and inducers, within 7 days prior to dosing * Administration of medications that prolong the QT interval within 4 weeks prior to dosing and until EOT. * History or current diagnosis of cardiac disease indicating significant risk of safety * Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs. Additional exclusion criteria for healthy subjects (control group): * Clinical evidence of liver disease or liver injury * History or presence of renal impairment as indicated by abnormal creatinine or BUN values * A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody Additional exclusion criteria for subjects with hepatic impairment: * Alcohol or drug abuse within one month prior to dosing or evidence of such * History of liver transplantation at any time in the past and is on immunosuppressant therapy. * Encephalopathy Grade 3 or worse within 28 days of dosing. * History of surgical portosystemic shunt. * Life expectancy ≤3 months Other protocol-defined inclusion/exclusion may apply.