To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Renal Impaired Subjects and Healthy Subjects
NCT ID: NCT02063204
Last Updated: 2015-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2014-03-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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HV selumetinib Stage 1
Healthy volunteer (HV)group to receive selumetinib 50mg (2x25mg) orally
selumetinib
selumetinib 50 mg (2x25mg) administered by mouth as capsules
ESRD selumetinib Stage 1
End stage renal disease (ESRD)patients to recieve selumetinib 50mg (2x25mg) orally
selumetinib
selumetinib 50 mg (2x25mg) administered by mouth as capsules
Selumetinib stage 2
If deemed necessary patients with mild and/or moderate and/or severe renal impairment will recieve selumetinib 50mg(2x25mg) orally
selumetinib
selumetinib 50 mg (2x25mg) administered by mouth as capsules
Interventions
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selumetinib
selumetinib 50 mg (2x25mg) administered by mouth as capsules
Eligibility Criteria
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Inclusion Criteria
2. Have a weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 40 kg/m2, inclusive.
Inclusion healthy volunteers only:
3. 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.
Inclusion renal impaired patients only:
4. Stable renal function
Exclusion Criteria
2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (e.g. China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable.
3. Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day
4. In the opinion of the investigator, any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or respiratory disease) or laboratory finding, physical examination, hematology, clinical chemistry, urinalysis, vital signs, or 12-lead ECG that makes it undesirable for the subject to participate in the study.
Exclusion renal impaired patients only:
5. Subjects with an active renal transplant (subjects who have previously received a renal transplant and are currently undergoing dialysis due to transplant failure may be enrolled).
6. Acute coronary syndrome within 6 months prior to administration of the investigational product.
18 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas C Marbury, MD
Role: PRINCIPAL_INVESTIGATOR
Orlando Clinical Research Centre, US
Ian Smith, MD
Role: STUDY_DIRECTOR
Astrazeneca United kingdom
Locations
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Research Site
Orlando, Florida, United States
Countries
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Related Links
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CSR\_Synopsis\_D1532C00081.pdf
Other Identifiers
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D1532C00081
Identifier Type: -
Identifier Source: org_study_id