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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca

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. -