Pharmacokinetics Study of Asciminib in Subjects With Impaired Renal Function Compared to Matched Healthy Volunteers

Exclusion Criteria

• •women of child-bearing potential / pregnant / nursing
• •contraindication or hypersensitivity to any drug or metabolites from similar class as asciminib or to any excipients of the study drug
• •cardiac or cardiac repolarization abnormality
• •history of psychiatric illness within the past 2 years
• •history of acute or chronic pancreatitis
• •subject on dialysis
• •smokers (use of tobacco products in the previous 3 months) and not willing to abstain from using tobacco during the study
• •any surgical or medical condition altering the absorption, distribution, metabolism or excretion of drug
• •history of immunodeficiency diseases, including a positive Human Immunodeficiency Virus (HIV) test result at screening
• •chronic infection with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) at screening
• •donation or loss of 400 mL or more of blood or plasma within 8 weeks prior to dosing or other amount considered to compromise the health of the subject if previous history of anemia exists
• •use of the following drugs within 28 days prior to dosing: drugs that prolong the QT interval; CYP3A4 inhibitors and inducers; BCRP, UGT and PgP inhibitors and inducers