To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers
NCT ID: NCT02093728
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
26 participants
INTERVENTIONAL
2014-04-30
2014-06-30
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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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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selumetinib; itraconazole; selumetinib + itraconazole
Volunteers will receive selumetinib 25mg alone; itraconazole 200mg pre-dosing; selumetinib 25mg and itraconazole 200mg; all adminstered by mouth as a capsule
selumetinib
Volunteers will recieve single oral dose of 25mg selumetinib in sequence 1, treatment A
itraconazole
Volunteers will receive oral doses of itraconazole 200 mg twice daily on Day 1 to Day 7 in sequence 1 treatment B:
itraconazole
Volunteers will recieve a single morning dose of 200mg itraconazole on Day 8 and twice daily doses of 200mg itraconazole on Day 8 to Day 11; sequence 1 treatment C.
selumetinib
Volunteers willl recieve a single oral dose of 25 mg selumetinib (4 hours fasted state) on Day 8; sequence 1 treatment C.
selumetinib; fluconazole; selumetinib + fluconazole
Volunteers will receive selumetinib 25mg alone administered by mouth as a capsule; fluconazole 400mg and fluconazole 200mg pre-dosing, administered by mouth as a tablet; selumetinib 25mg and fluconazole 200mg.
selumetinib
Volunteers will recieve single oral dose of 25mg selumetinib in sequence 2, treatment A.
fluconazole
Volunteers will recieve a single dose of 400 mg fluconazole on Day 1 and daily doses of 200 mg fluconazole on Day 2 to Day 7; sequence 2 treatment D.
fluconazole
Volunteers will receive a morning dose of 200mg fluconazole on Day 8 and daily doses of 200mg fluconazole on Day 8 to Day 11; sequence 2 treatment E
selumetinib
Volunteers will receive a single dose of 25mg selumetinib (4 hours fasted state) on Day 8; sequence 2 treatment E
Interventions
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selumetinib
Volunteers will recieve single oral dose of 25mg selumetinib in sequence 1, treatment A
itraconazole
Volunteers will receive oral doses of itraconazole 200 mg twice daily on Day 1 to Day 7 in sequence 1 treatment B:
itraconazole
Volunteers will recieve a single morning dose of 200mg itraconazole on Day 8 and twice daily doses of 200mg itraconazole on Day 8 to Day 11; sequence 1 treatment C.
selumetinib
Volunteers willl recieve a single oral dose of 25 mg selumetinib (4 hours fasted state) on Day 8; sequence 1 treatment C.
selumetinib
Volunteers will recieve single oral dose of 25mg selumetinib in sequence 2, treatment A.
fluconazole
Volunteers will recieve a single dose of 400 mg fluconazole on Day 1 and daily doses of 200 mg fluconazole on Day 2 to Day 7; sequence 2 treatment D.
fluconazole
Volunteers will receive a morning dose of 200mg fluconazole on Day 8 and daily doses of 200mg fluconazole on Day 8 to Day 11; sequence 2 treatment E
selumetinib
Volunteers will receive a single dose of 25mg selumetinib (4 hours fasted state) on Day 8; sequence 2 treatment E
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese. Asian (ie, China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable. 3. Current or past history of central serous retinopathy or retinal vein thrombosis,intra-ocular pressure \>21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
18 Years
45 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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David R Mathews, MD
Role: PRINCIPAL_INVESTIGATOR
Quintiles 6700 W 115th Street, Kansas, US
Locations
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Research Site
Overland Park, Kansas, United States
Countries
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Related Links
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Other Identifiers
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D1532C00083
Identifier Type: -
Identifier Source: org_study_id