To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects
- Registration Number
- NCT02063230
- Lead Sponsor
- AstraZeneca
- Brief Summary
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Selumetinib mild impairment Selumetinib 50mg Mild (Child Pugh A) hepatic impaired patients Selumetinib moderate impairment Selumetinib 50mg Moderate (Child Pugh B) hepatic impaired patients Selumetinib severe impairment Selumetinib 25mg Severe (Child Pugh C) hepatic impairment patients Selumetinib HV Selumetinib 50mg Healthy volunteers (HV)
- Primary Outcome Measures
Name Time Method 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 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Selumetinib in hepatic impairment patients with solid tumors?
How does Selumetinib's efficacy compare to standard-of-care treatments in patients with hepatic impairment and solid tumors?
Which biomarkers are associated with response to Selumetinib in patients with hepatic impairment and solid tumors?
What are the potential adverse events of Selumetinib in hepatic impairment patients and how can they be managed?
Are there any combination therapies or competitor drugs for MEK inhibition in hepatic impairment patients with solid tumors?
Trial Locations
- Locations (1)
Research Site
🇺🇸Orlando, Florida, United States
Research Site🇺🇸Orlando, Florida, United States