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

Part of paid clinical trials in Orlando, Florida.

Sponsor
AstraZeneca
Study ID
NCT02063230
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Mar 31, 2014
Status verified
Jun 2016
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Selumetinib HV
    Healthy volunteers (HV)
  • Experimental: Selumetinib mild impairment
    Mild (Child Pugh A) hepatic impaired patients
  • Experimental: Selumetinib moderate impairment
    Moderate (Child Pugh B) hepatic impaired patients
  • Experimental: Selumetinib severe impairment
    Severe (Child Pugh C) hepatic impairment patients

Primary Outcome Measure

AUC (0 to Infinity) of Total Selumetinib [ Time Frame: 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOrlandoFlorida--

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By research site
Research Site· Orlando, FL

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