To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-11-30

Brief Summary

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A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.

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Detailed Description

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An open label study to assess the pharmcokinetics, safety and tolerability of a single dose of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.

Conditions

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Solid Tumors

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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Selumetinib HV

Healthy volunteers (HV)

Group Type EXPERIMENTAL

Selumetinib 50mg

Intervention Type DRUG

HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1

Selumetinib mild impairment

Mild (Child Pugh A) hepatic impaired patients

Group Type EXPERIMENTAL

Selumetinib 50mg

Intervention Type DRUG

HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1

Selumetinib moderate impairment

Moderate (Child Pugh B) hepatic impaired patients

Group Type EXPERIMENTAL

Selumetinib 50mg

Intervention Type DRUG

HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1

Selumetinib severe impairment

Severe (Child Pugh C) hepatic impairment patients

Group Type EXPERIMENTAL

Selumetinib 25mg

Intervention Type DRUG

Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1

Interventions

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Selumetinib 50mg

HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1

Intervention Type DRUG

Selumetinib 25mg

Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects will be males or females (non-childbearing potential) aged 18 years or more and with a weight of at least 45 kg and a BMI between 18 and 40 kg/m2 inclusive.

Inclusion Critera only for hepatic impaired patients:
2. Subjects with stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study.

3. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead ECG, clinical laboratory evaluations, and an ophthalmic examination performed before the administration of the investigational product.

Exclusion Criteria

1. Subjects of Japanese or non-Japanese Asian ethnicity
2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (eg, China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian Indians are acceptable.
3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the investigational product
4. Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day.

5. Undergone liver transplantation. -

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes