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

• Status: Completed
• Trial end date: 2019-04-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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