Study of Single-dose DS-3201b in Participants With Hepatic Impairment

Exclusion Criteria

• •Clinically relevant abnormal history, physical findings, electrocardiogram, or laboratory values at the Screening assessment that could interfere with the objectives of the study or the safety of the participant
• •Participants with primary biliary cirrhosis or primary sclerosing cholangitis
• •Participants with history of Gilbert's syndrome
• •Use of any drugs or substances known to be moderate/strong inhibitors or inducers of CYP3A4 and 3A5 enzymes or P-glycoprotein (P-gp) inhibitors within 14 days or 5 half-lives, if known, of the drugs or substances, whichever is greater, prior to study drug administration
• •Receipt of any prescribed or over-the-counter (OTC) systemic, herbal (including St John's wort), or topical medication within 14 days of study drug administration, or any expectation of requiring use of such medication while participating in the study is prohibited
• •Presence or history of clinically severe adverse reaction to any drug
• •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (with the exception of appendectomy, hernia repair, and/or cholecystectomy)
• •History of any cancer, except non-melanoma skin cancer, or resected non-metastatic cancer with no evidence of disease accepted by the Investigator and Sponsor medical monitor
• •A positive drugs of abuse screen from a urine ethanol test (unless the drug is medically prescribed by a licensed health care provider) or alcohol breath test at Screening or at Check-in on Day -2 or a participant who will not agree to smoke ≤10 cigarettes or equivalent per day from Screening up to Enrollment, and is unable to be restricted to ≤5 cigarettes per day and for 6 hours post dose during their period of residence in the clinical unit
• •Concomitant use of medications known to affect the elimination of serum creatinine (eg, trimethoprim or cimetidine) and inhibitors of renal tubular secretion (eg, probenecid) within 14 days or 5 half-lives, if known, of the drugs, whichever is greater, prior to study drug administration
• •History or presence of an abnormal electrocardiogram, which, in the investigator's opinion, is clinically significant and/or a QT interval corrected for heart rate using Fridericia's formula ≥450 milliseconds (ms) and ≥470 ms for healthy male and female participants, respectively, and \>500 ms for subjects with hepatic impairment at Screening
• •Consumption of alcohol- and caffeine-containing beverages within 72 hours prior to Check-in and during confinement
• •History of moderate to heavy alcohol use defined as consumption of more than 28 units of alcohol per week for males or 14 units of alcohol per week for females, where 1 unit of alcohol equals one-half pint of beer, 4 ounces (oz) of wine, or 1 oz of spirits, or significant history of alcoholism or drug/chemical abuse within the last 2 years
• •Positive serology for hepatitis B surface antigen (HBsAg) and HCV (healthy participants), hepatitis A virus (HAV) immunoglobulin M, or anti-human immunodeficiency virus (HIV) Type 1 and Type 2 (participants)
• •Loss of more than 450 mL blood during the 3 months before the trial (eg, as a blood donor)
• •Current enrollment in or have not yet completed at least 30 days or 5 elimination half-lives, whichever is longer, since receiving an investigational device or product, or receipt of other investigational agents within 30 days of DS-3201b
• •In the opinion of the investigator, history of a clinically significant illness within 4 wk prior to administration of study drug
• •Women of childbearing potential without proper nonhormonal or barrier contraceptive measures and women who are pregnant or breastfeeding. Male and female participants may be excluded from the study if the primary investigator at the site forbids specific methods of contraception they are using.
• •Start of any new medication or any changes to a current dosage within 14 days prior to study drug administration excluding approved oral contraceptives
• •Any clinically relevant abnormality identified on the physical examination, electrocardiogram, vital signs, or laboratory tests at Screening
• •Liver function (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], alkaline phosphatase (ALP) of liver origin, gamma glutamyltransferase \[GGT\], and Total bilirubin \[TBil\]) test results above the ULN at Screening and during Enrollment on Day -2 are exclusionary. If transaminase levels are \>2 × ULN at Screening the participant will be excluded and cannot be rescreened
• •Participants with active stage 3 or stage 4 encephalopathy
• •Fluctuating or rapidly deteriorating hepatic function as indicated by recent history or worsening of clinical and/or laboratory signs of hepatic impairment as judged by the investigator
• •Participants with known portal hypertension and/or had shunting procedures done