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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Selumetinib 50mg; Drug: Selumetinib 25mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02063230

D1532C00082

Details and patient eligibility

About

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

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for all participants:

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.

   Inclusion Criteria only for healthy volunteers:

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 for all participants:

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.

   Exclusion criteria for hepatic impaired patients only

5. Undergone liver transplantation. -

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 4 patient groups

Selumetinib HV

Experimental group

Description:

Healthy volunteers (HV)

Treatment:

Drug: Selumetinib 50mg

Selumetinib mild impairment

Experimental group

Description:

Mild (Child Pugh A) hepatic impaired patients

Treatment:

Drug: Selumetinib 50mg

Selumetinib moderate impairment

Experimental group

Description:

Moderate (Child Pugh B) hepatic impaired patients

Treatment:

Drug: Selumetinib 50mg

Selumetinib severe impairment

Experimental group

Description:

Severe (Child Pugh C) hepatic impairment patients

Treatment:

Drug: Selumetinib 25mg