Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-04

Study Completion Date

2016-12-08

Brief Summary

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This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokinetics of alectinib.

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alectinib: Moderate Hepatic Impairment

Participants with moderate hepatic impairment (based on Child-Pugh score) will receive alectinib at a single oral dose of 300 milligrams (mg) on Day 1.

Group Type EXPERIMENTAL

Alectinib

Intervention Type DRUG

Participants will receive alectinib as per the dosage schedule mentioned in arm description.

Alectinib: Severe Hepatic Impairment

Participants with severe hepatic impairment (based on Child-Pugh score) will receive alectinib at a single oral dose of 300 mg on Day 1.

Group Type EXPERIMENTAL

Alectinib

Intervention Type DRUG

Participants will receive alectinib as per the dosage schedule mentioned in arm description.

Alectinib: Normal Hepatic Function

Participants with normal hepatic function will receive alectinib at a single oral dose of 300 mg on Day 1.

Group Type EXPERIMENTAL

Alectinib

Intervention Type DRUG

Participants will receive alectinib as per the dosage schedule mentioned in arm description.

Interventions

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Alectinib

Participants will receive alectinib as per the dosage schedule mentioned in arm description.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All Participants

* Body mass index between 18 to 35 kilograms per square meter (kg/m\^2) inclusive and weight greater than (\>) 50 kilograms (kg)
* Female participants must be surgically sterile or post-menopausal
* Male participants and their partners of child-bearing potential must be willing to use 2 effective methods of contraception, one of which must be a barrier method

Participants with Hepatic Impairment

\- Documented chronic stable liver disease (Child-Pugh Class A, B or C)

Exclusion Criteria

All Participants

* Pregnant or lactating women, males with female partners who are pregnant or lactating, or women of child bearing potential
* Positive test for drugs of abuse or alcohol
* Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to study drug administration
* History of hypersensitivity to any of the additives in the alectinib formulation
* Participants under judicial supervision, guardianship, or curatorship
* History of severe drug-related allergic reactions or drug-induced hepatotoxicity

Healthy Participants

* Use of any medications (prescription or over-the-counter), within 2 weeks or 5 half-lives (whichever longer) prior to study drug administration
* Use of any herbal supplements or any metabolic inducers within 4 weeks, or 5 half-lives (whichever is longer) prior to study drug administration

Participants with Hepatic Impairment

* Positive screening test for human immunodeficiency virus (HIV)
* History of liver transplantation
* Hepatocellular carcinoma or acute liver disease
* Severe ascites at screening or admission to the clinic
* Recent history (past 2 years) or current severe hepatic encephalopathy (Grade 3 or higher)
* Any evidence of progressive liver disease within the last 4 weeks
* Presence of surgically created or transjugular intrahepatic portal systemic shunts

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes