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Sponsors and Collaborators: |
Amylin Pharmaceuticals, Inc. Eli Lilly and Company |
Information provided by: | Amylin Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00672399 |
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.
Condition | Intervention | Phase |
Healthy Subjects |
Drug: exenatide Drug: moxifloxacin Drug: placebo |
Phase I |
Drug Information available for: | Exenatide Moxifloxacin Moxifloxacin hydrochloride |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 80 |
Study Start Date: | April 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: exenatide
subcutaneous, 10mcg, QD
Drug: moxifloxacin
oral, 400mcg, QD
Drug: placebo
oral,400mcg,QD or subcutaneous, 10mcg, QD
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2: Experimental |
Drug: exenatide
subcutaneous, 10mcg, QD
Drug: moxifloxacin
oral, 400mcg, QD
Drug: placebo
oral,400mcg,QD or subcutaneous, 10mcg, QD
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3: Experimental |
Drug: exenatide
subcutaneous, 10mcg, QD
Drug: moxifloxacin
oral, 400mcg, QD
Drug: placebo
oral,400mcg,QD or subcutaneous, 10mcg, QD
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4: Experimental |
Drug: exenatide
subcutaneous, 10mcg, QD
Drug: moxifloxacin
oral, 400mcg, QD
Drug: placebo
oral,400mcg,QD or subcutaneous, 10mcg, QD
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5: Experimental |
Drug: exenatide
subcutaneous, 10mcg, QD
Drug: moxifloxacin
oral, 400mcg, QD
Drug: placebo
oral,400mcg,QD or subcutaneous, 10mcg, QD
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6: Experimental |
Drug: exenatide
subcutaneous, 10mcg, QD
Drug: moxifloxacin
oral, 400mcg, QD
Drug: placebo
oral,400mcg,QD or subcutaneous, 10mcg, QD
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Plymouth | |||||
Reseach Site | |||||
Derriford, Plymouth, United Kingdom | |||||
United Kingdom, West Yorkshire | |||||
Research Site | |||||
Leeds, West Yorkshire, United Kingdom |
Amylin Pharmaceuticals, Inc. |
Eli Lilly and Company |
Study Director: | James Malone, MD | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company ( James Malone, MD, Study Director ) |
Study ID Numbers: | H8O-EW-GWCI |
First Received: | May 1, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00672399 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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