Study to investigate relative bioavailability of up to five different formulations of AZD5069
Study identifier:D3551C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers
Medical condition
Uncontrolled and persistent asthma
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Phase IIb formulation, Putative phase III formulation, Slow dissolution variant 1, Slow dissolution variant 2, Test treatment E
Sex
All
Actual Enrollment
36
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 01 Jan 2014
Primary Completion Date: 01 Apr 2014
Study Completion Date: 01 Apr 2014
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jun 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
N/A
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment A Phase IIb formulation | Drug: Phase IIb formulation Single oral dose 45mg AZD5069 |
| Experimental: Treatment B Putative phase III formulation | Drug: Putative phase III formulation Single oral dose 45mg AZD5069 |
| Experimental: Treatment C Slow dissolution variant 1 | Drug: Slow dissolution variant 1 Single oral dose 45mg AZD5069 |
| Experimental: Treatment D Slow dissolution variant 2 | Drug: Slow dissolution variant 2 Single oral dose 45mg AZD 5069 |
| Experimental: Treatment E Optional treatment that may use one of 3 45 mg (intermediate dissolution variant) of AZD5069 | Drug: Test treatment E Tablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069 |
Contacts
Investigators
Principal Investigator
Olufeyikemi Oluwayi
Quintiles London UK
