To assess the pharmacokinetics, safety and tolerability of selumetinib in patients with hepatic impairment and healthy subjects
Study identifier:D1532C00082
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Solid Tumors
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Selumetinib 50mg, Selumetinib 25mg
Sex
All
Actual Enrollment
32
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 01 Mar 2014
Primary Completion Date: 01 Nov 2014
Study Completion Date: 01 Nov 2014
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jun 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Selumetinib HV Healthy volunteers (HV) | Drug: Selumetinib 50mg HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1 |
| Experimental: Selumetinib mild impairment Mild (Child Pugh A) hepatic impaired patients | Drug: Selumetinib 50mg HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1 |
| Experimental: Selumetinib moderate impairment Moderate (Child Pugh B) hepatic impaired patients | Drug: Selumetinib 50mg HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1 |
| Experimental: Selumetinib severe impairment Severe (Child Pugh C) hepatic impairment patients | Drug: Selumetinib 25mg Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1 |
Contacts
Investigators
Principal Investigator
Thomas C Marbury
Orlando Clinical Research Center, 5055 S Orange Avenue, Orlando, Florida, United States.
