Study identifier:D9120C00030
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A phase 1 single centre single-blind randomised placebo-controlled study to assess the safety, tolerability and pharmacokinetics of oral AZD3355 after administration of single ascending doses and multiple repeated doses in healthy male volunteers
Reflux disease
Phase 1
Yes
AZD3355, Placebo
Male
54
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo ("inactive substance"). Safety and tolerability variables will be closely monitored throughout the study.
Location
Location
Gothenburg, Sweden
Arms | Assigned Interventions |
---|---|
Experimental: 1 | Drug: AZD3355 capsules, oral, single or twice daily dose Other Name: Lesogaberan |
Placebo Comparator: 2 | Drug: Placebo To match dosing of AZD3355 |
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