Conditions: Hepatic Impairment Healthy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 44
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared with subjects with healthy normal liver function.

Detailed description:

Arms:
arm 1: The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: SSP-004184
Intervention descriptions: intervention 1: All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1

Protocol document: