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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-16

Study Completion Date

2019-04-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Normal renal function

healthy volunteers with normal renal function

Group Type EXPERIMENTAL

Asciminib

Intervention Type DRUG

40 mg single dose

Severe renal impairment

subjects with severe renal impairment

Group Type EXPERIMENTAL

Asciminib

Intervention Type DRUG

40 mg single dose

Moderate renal impairment

subject with moderate renal impairment

Group Type EXPERIMENTAL

Asciminib

Intervention Type DRUG

40 mg single dose

Mild renal impairment

subjects with mild renal impairment

Group Type EXPERIMENTAL

Asciminib

Intervention Type DRUG

40 mg single dose

Interventions

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Asciminib

40 mg single dose

Intervention Type DRUG

Other Intervention Names

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ABL001

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes