a study to investigate the effect of hepatic impairment on the pharmacokinetics and safety and tolerability of a single oral dose of risdiplam compared to matched healthy participants with normal hepatic function

Conditions: Muscular Atrophy, Spinal

Summary: this is a multi-center, open-label, non-randomized, parallel-group, 2-part study to evaluate the effect of hepatic impairment on the pk and safety and tolerability of a single oral dose of risdiplam compared to matched healthy participants with normal hepatic function.


Eligibility criteria:
inclusion criteria: all participants: * bmi between 18.0 and 36.0 kilograms per square metre (kg/m2), inclusive, and body weight \> / = 50 kg * females must not be pregnant or lactating and must be of non-childbearing potential * male participants (whether surgically sterilized or not) with female partners of childbearing potential must use methods of contraception from screening until 4 months after their dose of the study drug as detailed in the protocol * male participants must not donate sperm from check-in (day -1) until 4 months after their dose of the study drug participants with normal hepatic function only: * matched to participants with mild or moderate hepatic function in sex, age, bmi, and smoking status * in good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead ecg, vital sign measurements, and clinical laboratory evaluations participants with hepatic impairment only: * documented chronic stable liver disease * currently on a stable medication regimen, defined as not starting new drug(s) or changing drug dose(s) within 3 months of administration of study drug * anemia secondary to hepatic disease will be acceptable, if hemoglobin \>/= 9 gram per decilitre (g/dl). participants must have a platelet count \</= 35 000 platelets exclusion criteria: all participants * significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder * history of significant hypersensitivity, intolerance, or allergy to any drug compound, constituents or excipients of the study drug, food, or other substance * history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered * ventricular dysfunction or history of risk factors for torsades de pointes * evidence of hepatorenal syndrome and estimated creatinine clearance range \< 60 millilitre per minute (ml/min) or abnormal sodium and potassium levels * clinically significant physical examination abnormality * history of diabetes mellitus * use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including st. john's wort * positive human immunodeficiency virus (hiv) test * participation in a clinical study involving administration of an investigational drug prior to dosing * smoke more than 10 cigarettes or use the equivalent tobacco- or nicotine-containing products per day * receipt of blood products within 2 months prior to study * donation of blood, plasma, or platelets prior to screening * poor peripheral venous access * have previously completed or withdrawn from this study or any other study investigating risdiplam, and have previously received the investigational product participants with normal hepatic function only: * confirmed supine blood pressure \> 150 millimetre of mercury (mmhg) or \< 90 mmhg * positive test for hepatitis b or c virus * clinically significant abnormal laboratory values * significant history or clinical manifestation of hepatic disorder * history or presence of liver disease or liver injury * use or intend to use any prescription medications/products within 14 days prior to dosing -. use or intend to use slow-release medications/products considered to still be active within 14 days prior to dosing * use or intend to use any non-prescription medications/products within 7 days prior to dosing participants with hepatic impairment only: * confirmed supine blood pressure \> 159 mmhg or \< 90 mmhg * values outside the normal range for liver function tests that are not consistent with their hepatic condition * use of a new medication, or a change in dose, for the treatment, or worsening of, hepatic encephalopathy * use of prescription drugs within 14 days of study drug administration * recent history of, or the treatment of, esophageal bleeding * presence of a portosystemic shunt * recent history of paracentesis * current functioning organ transplant or are waiting for an organ transplant * evidence of severe ascites * history or current symptoms of hepatic encephalopathy grade 2 or above