To Assess the Effect of Food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers
Study identifier:D1532C00069
ClinicalTrials.gov identifier:NCT01974349
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomized, Open-label, Single-center, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers Aged 18 to 45 Years
Medical condition
Solid tumours
Phase
Phase 1
Healthy volunteers
Yes
Study drug
selumetinib (oral)
Sex
Male
Actual Enrollment
39
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 13 Nov 2013
Primary Completion Date: 16 Feb 2014
Study Completion Date: 16 Feb 2014
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Oct 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: selumetinib 75mg (oral capsule fasted) Volunteers will recieve selumetinib 75mg administered by mouth, as a capsule, in a fasted state. | Drug: selumetinib (oral) Volunteers will receive: 75 mg selumetinib oral dose in a fasted state (Treatment A) followed by a second 75 mg selumetinib oral dose in the fed state (Treatment B) with a washout period of at least 7 days between doses, or: 75 mg selumetinib oral dose in the fed state (Treatment B) followed by a second 75 mg selumetinib oral dose in the fasted state (Treatment A) with a washout period of at least 7 days between doses. Other Name: AZD6244 |
| Experimental: selumetinib 75mg (oral capusle fed) Volunteers will receive selumetinib 75mg administered by mouth, as a capsule, in a fed state. | Drug: selumetinib (oral) Volunteers will receive: 75 mg selumetinib oral dose in a fasted state (Treatment A) followed by a second 75 mg selumetinib oral dose in the fed state (Treatment B) with a washout period of at least 7 days between doses, or: 75 mg selumetinib oral dose in the fed state (Treatment B) followed by a second 75 mg selumetinib oral dose in the fasted state (Treatment A) with a washout period of at least 7 days between doses. Other Name: AZD6244 |
Contacts
Investigators
Principal Investigator
Eleanor Lisbon
Quintiles 6700 W 115th Street, Kansas, US
