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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1 = placebo exenatide/placebo moxifloxacin; Period II = exenatide/placebo moxifloxacin; Period III = placebo exenatide/moxifloxacin |
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| Sequence 2 | Experimental | Period I = exenatide/placebo moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = placebo exenatide/placebo moxifloxacin |
|
| Sequence 3 | Experimental | Period 1 = placebo exenatide/moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = exenatide/placebo moxifloxacin |
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| Sequence 4 | Experimental | Period I = placebo exenatide/moxifloxacin; Period II = exenatide/placebo moxifloxacin; Period III = placebo exenatide/placebo moxifloxacin |
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| Sequence 5 | Experimental | Period I = placebo exenatide/placebo moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = exenatide/moxifloxacin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | Subcutaneously injected, 10 mcg, single doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | single doses - measurements at 1, 2, 3, 4, 5.5 and 10 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | single doses - samples drawn at and EKGs at -15 min, hours 1, 2, 3, 4, 5.5, 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Malone, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reseach Site | Derriford | Plymouth | United Kingdom | |||
| Research Site |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Sequence 6 | Experimental | Period I = exenatide/placebo moxifloxacin; Period II = placebo exenatide/placebo moxifloxacin; Period III = placebo exenatide/moxifloxacin |
|
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| Moxifloxacin | Drug | oral, 400 mg tablet, single doses |
|
| Placebo | Drug | Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses |
|
| Assessment of plasma exenatide concentrations and QTc interval |
Evaluation of the relationship between plasma exenatide concentrations and QTc interval in healthy subjects |
| During Periods I, II, and III, ECGs should be recorded at the following |
| Leeds |
| West Yorkshire |
| United Kingdom |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |