To determine the relative bioavailability of different formulations of AZD9291 and the effect of food.
Study identifier:D5160C00005
ClinicalTrials.gov identifier:NCT01951599
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD9291
Sex
Male
Actual Enrollment
35
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 09 Oct 2013
Primary Completion Date: 04 Jun 2014
Study Completion Date: 04 Jun 2014
Study design
Allocation: N/A
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Mar 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD9291 20mg (oral capsule fasted) Volunteers will receive AZD9291 20mg administered by mouth, as a capsule, in the fasted state. | Drug: AZD9291 Volunteers will receive a single 20-mg dose of AZD9291 as a capsule on day 1, in Part A, Period 1, in the fasted state. (Treatment A). |
| Experimental: AZD9291 20mg (oral solution fasted) Volunteers will receive AZD9291 20mg administered by mouth, as a solution, in the fasted state. | Drug: AZD9291 Volunteers will receive a single 20-mg dose of AZD9291 as a solution on day 1, in Part A, Period 2, in the fasted state. (Treatment B). |
| Experimental: AZD9291 20mg (oral tablet fasted) Volunteers will receive AZD9291 20mg administered by mouth, as a tablet, in the fasted state. | Drug: AZD9291 Volunteers will receive a single 20-mg dose of AZD9291 as a tablet on day 1, in Part A, Period 3, in the fasted state. (Treatment C). |
| Experimental: AZD9291 20mg (oral fasted) Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fasted state. | Drug: AZD9291 Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 1, in the fasted state. |
| Experimental: AZD9291 20mg (oral fed) Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fed state. | Drug: AZD9291 Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 2, in the fed state. |
Contacts
Investigators
Principal Investigator
Phil Leese
Quintiles 6700 W 115th Street, Kansas, US
