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

NCT02063230 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-07-21

Study results available
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Summary

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

Conditions

Interventions

DRUG

Selumetinib 50mg

HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1

DRUG

Selumetinib 25mg

Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1

Sponsors & Collaborators

Principal Investigators

  • Thomas C Marbury, MD · Orlando Clinical Research Center, 5055 S Orange Avenue, Orlando, Florida, United States.

  • Ian Smith, MD · Astrazeneca, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02063230 on ClinicalTrials.gov