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

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ClinicalTrials.gov Identifier: NCT02063230
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : November 1, 2015
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Selumetinib 50mg Drug: Selumetinib 25mg Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Selumetinib

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Cmax 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 ]
  3. Dose Normalized AUC, 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 ]
  4. Dose Normalized Cmax, 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 ]
  5. Dose Normalized AUC, Unbound 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 ]
  6. Dose Normalized Cmax, Unbound 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063230


Locations
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United States, Florida
Research Site
Orlando, Florida, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Thomas C Marbury, MD Orlando Clinical Research Center, 5055 S Orange Avenue, Orlando, Florida, United States.
Study Director: Ian Smith, MD Astrazeneca, UK
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02063230    
Other Study ID Numbers: D1532C00082
First Posted: February 14, 2014    Key Record Dates
Results First Posted: November 1, 2015
Last Update Posted: July 21, 2016
Last Verified: June 2016
Keywords provided by AstraZeneca:
Phase I, healthy, pharmacokinetic, hepatic impairment
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases