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

A Phase I, Open-label and Single-dose Study to Evaluate the Pharmacokinetics and Safety of a Single 40 mg Oral Dose of ABL001 (Asciminib) in Subjects With Impaired Renal Function Compared to Matched Control Subjects With Normal Renal Function

The purpose of this study is to characterize the pharmacokinetics (PK) and safety profile of asciminib following a single oral dose in adult subjects with renal impairment compared to a matched group of healthy subjects with normal renal function.

The results will determine whether or not a dose adjustment should be recommended when treating patients with asciminib who have impaired renal function.

Inclusion Criteria:

• Male or sterile / post-menopausal female
• BMI between 18 and 36 kg/m2, body weight greater than or equal to 50 kg and no more than 120 kg
• Adequate venous access for blood sampling
• For healthy volunteers: subject must be matched to at least one renal impaired subject by age (+/- 10 years), body weight (+/- 20%) and gender
• For renal impaired subjects: documented stable renal disease without evidence of progressive decline in renal function (stable renal disease is defined as no significant change, such as, stable aGFR < 90, for 12 weeks prior to study entry)

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

Other protocol-defined inclusion/exclusion criteria may apply