Study to investigate the pharmacodynamic effect of a single dose of AZD2516 in healthy male subjects
Study identifier:D3830C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers
Medical condition
Reflux
Phase
Phase 2
Healthy volunteers
Yes
Study drug
AZD2516, 5 mg, AZD2516, 16 mg, AZD2516, 40 mg, Placebo
Sex
Male
Actual Enrollment
20
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 May 2010
Primary Completion Date: 01 Sept 2010
Study Completion Date: 01 Sept 2010
Study design
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Aug 2012 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: First 5 mg, then placebo, then 16 mg, then 40 mg period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg. | Drug: AZD2516, 5 mg Capsule, oral Drug: AZD2516, 16 mg Capsule, oral Drug: AZD2516, 40 mg Capsule, oral Drug: Placebo Capsule, oral |
| Experimental: First 40 mg, then 16 mg, then placebo, then 5 mg period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg. | Drug: AZD2516, 5 mg Capsule, oral Drug: AZD2516, 16 mg Capsule, oral Drug: AZD2516, 40 mg Capsule, oral Drug: Placebo Capsule, oral |
| Experimental: First 16 mg, then 5 mg, then 40 mg, then placebo period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo. | Drug: AZD2516, 5 mg Capsule, oral Drug: AZD2516, 16 mg Capsule, oral Drug: AZD2516, 40 mg Capsule, oral Drug: Placebo Capsule, oral |
| Experimental: First placebo, then 40 mg, then 5 mg, then 16 mg period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg | Drug: AZD2516, 5 mg Capsule, oral Drug: AZD2516, 16 mg Capsule, oral Drug: AZD2516, 40 mg Capsule, oral Drug: Placebo Capsule, oral |
Contacts
Investigators
Principal Investigator
Mark Berner Hansen
AstraZeneca R&D Molndal
