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
Verified date | December 2015 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
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. - |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States,
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 |
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