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

Solid Tumors Clinical Trial

Official title:

An Open-label, Comparative Study to Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY-142886) (Hyd-Sulfate) Following Single Oral Dosing to Healthy Subjects and to Subjects With Mild, Moderate, and Severe Hepatic Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063230
• Other study ID #: D1532C00082
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2014
• Last updated: December 21, 2015
• Start date: March 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 130 Years

Eligibility

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. -

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Liver Diseases
• Solid Tumors

Intervention

Drug:
• Selumetinib 50mg
HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1
• Selumetinib 25mg
Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1

Locations

Country	Name	City	State
United States	Research Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (0 to Infinity) of Total Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose	0 to 120 hours	No
Primary	Cmax of Total Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose	0 to 120 hours	No
Secondary	Dose Normalized AUC, Total Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose	0 to 120 hours	No
Secondary	Dose Normalized Cmax, Total Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose	0 to 120 hours	No
Secondary	Dose Normalized AUC, Unbound Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose	0 to 120 hours	No
Secondary	Dose Normalized Cmax, Unbound Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose	0 to 120 hours	No