Clinical research study to find out if the drug dabrafenib is safe and to determine how dabrafenib is metabolized (broken down in the body) by people who have varying degrees of liver impairment (a condition in which the liver is not working as well as it normally should) compared with people who do not have liver (hepatic) impairment.
phase I study
You will check into the study clinic on Day -1 and You will remain at the study clinic for 6 days continuously starting from the day before you take the study drug (Day -1 to Day 5).
Male and/or female subjects 18-75 years of age on the day of Informed Consent signature.
Body mass index (BMI) between ≥18.0 and ≤38.0 kg/m2, with body weight ≥ 110 lbs and no more than 300 lbs
Confirmed hepatic disease by at least one of the following criteria:
- Histologically by prior liver biopsy showing cirrhosis.
- Clinically by physical examination (e.g., liver firmness to palpation, splenic
enlargement, spider angioma, palmar erythema, parotid hypertrophy, testicular
atrophy, ascites, presence of asterixis or gynecomastia).