Study identifier:H8O-EW-GWCI
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Placebo- and Positive-Controlled Study of the Electrophysiological Effects of a Single 10 μg Dose of Exenatide on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects
Healthy subjects
Phase 1
Yes
exenatide, Moxifloxacin, Placebo
All
70
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Eli Lilly and Company
This Phase 1, randomized, three period, placebo- and positive-controlled,double-blind, double-dummy, crossover study will be performed with approximately 80 healthy male and female subjects. The effects of single doses of exenatide (10 μg, subcutaneous), moxifloxacin (400 mg, oral) or placebo(subcutaneous or oral) on QT interval will be assessed.
Location
Location
Leeds, West Yorkshire, United Kingdom
Location
Derriford, Plymouth, United Kingdom
Arms | Assigned Interventions |
---|---|
Experimental: Sequence 1 Period 1 = placebo exenatide/placebo moxifloxacin; Period II = exenatide/placebo moxifloxacin; Period III = placebo exenatide/moxifloxacin | Drug: exenatide Subcutaneously injected, 10 mcg, single doses Other Name: Byetta Drug: Moxifloxacin oral, 400 mg tablet, single doses Drug: Placebo Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses |
Experimental: Sequence 2 Period I = exenatide/placebo moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = placebo exenatide/placebo moxifloxacin | Drug: exenatide Subcutaneously injected, 10 mcg, single doses Other Name: Byetta Drug: Moxifloxacin oral, 400 mg tablet, single doses Drug: Placebo Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses |
Experimental: Sequence 3 Period 1 = placebo exenatide/moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = exenatide/placebo moxifloxacin | Drug: exenatide Subcutaneously injected, 10 mcg, single doses Other Name: Byetta Drug: Moxifloxacin oral, 400 mg tablet, single doses Drug: Placebo Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses |
Experimental: Sequence 4 Period I = placebo exenatide/moxifloxacin; Period II = exenatide/placebo moxifloxacin; Period III = placebo exenatide/placebo moxifloxacin | Drug: exenatide Subcutaneously injected, 10 mcg, single doses Other Name: Byetta Drug: Moxifloxacin oral, 400 mg tablet, single doses Drug: Placebo Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses |
Experimental: Sequence 5 Period I = placebo exenatide/placebo moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = exenatide/moxifloxacin | Drug: exenatide Subcutaneously injected, 10 mcg, single doses Other Name: Byetta Drug: Moxifloxacin oral, 400 mg tablet, single doses Drug: Placebo Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses |
Experimental: Sequence 6 Period I = exenatide/placebo moxifloxacin; Period II = placebo exenatide/placebo moxifloxacin; Period III = placebo exenatide/moxifloxacin | Drug: exenatide Subcutaneously injected, 10 mcg, single doses Other Name: Byetta Drug: Moxifloxacin oral, 400 mg tablet, single doses Drug: Placebo Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses |
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