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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
70
Subcutaneously injected, 10 mcg, single doses
oral, 400 mg tablet, single doses
Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses
Reseach Site
Derriford, Plymouth, United Kingdom
Research Site
Leeds, West Yorkshire, United Kingdom
Comparison of exenatide's effect on QT interval when compared to placebo
To determine, in healthy subjects, that a single 10 μg dose of exenatide does not differ from placebo in the mean change from predose in 12-lead ECG correct QT (QTc) interval measurements
Time frame: single doses - measurements at 1, 2, 3, 4, 5.5 and 10 hours after dosing
Measurement of any QTcF changes following exenatide versus glucose, potassium, and insulin
To explore the influence of potential physiological covariates such as plasma insulin, plasma glucose, and potassium on QTc interval in healthy subjects
Time frame: single doses - samples drawn at and EKGs at -15 min, hours 1, 2, 3, 4, 5.5, 10
Assessment of plasma exenatide concentrations and QTc interval
Evaluation of the relationship between plasma exenatide concentrations and QTc interval in healthy subjects
Time frame: During Periods I, II, and III, ECGs should be recorded at the following
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