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

Novartis

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Asciminib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03605277

2018-001394-25 (EudraCT Number)

CABL001A2105

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

Normal renal function

Experimental group

Description:

healthy volunteers with normal renal function

Treatment:

Drug: Asciminib

Severe renal impairment

Experimental group

Description:

subjects with severe renal impairment

Treatment:

Drug: Asciminib

Moderate renal impairment

Experimental group

Description:

subject with moderate renal impairment

Treatment:

Drug: Asciminib

Mild renal impairment

Experimental group

Description:

subjects with mild renal impairment

Treatment:

Drug: Asciminib