Healthy Subjects Clinical Trial
Official title:
A Randomized, Phase 1, Three-Period, Placebo- and Positive-Controlled, Double-Blind, Crossover Study to Assess the Electrophysiological Effects of Exenatide at Therapeutic and Supratherapeutic Concentrations on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects
Verified date | March 2015 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.
Status | Completed |
Enrollment | 94 |
Est. completion date | May 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Is overtly healthy, as determined by medical history and physical examination - Has body mass index (BMI) between 25 and 35 kg/m2 - Has fasting serum glucose <110 mg/dL - Has no clinically significant blood pressure or heart rate readings as judged by the investigator at study start - Has electrocardiogram (ECG) results judged as not clinically significant by the investigator at study start Exclusion Criteria: - Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being - Has an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as a Bazett's corrected QT (QTcB) interval >450 ms. - Family history of sudden death - Personal history of unexplained syncope within last year, or family history of Long QT Syndrome, or significant active cardiac disease, or symptoms of angina pectoris or transient ischemic attacks within the previous 6 months |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Daytona Beach | Florida |
United States | Research Site | Evansville | Indiana |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Eli Lilly and Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL) | Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a mixed-effects model for repeated measures (MMRM) between exenatide and placebo. | Baseline, Day 1 | No |
Primary | Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL) | Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo. | Baseline, Day 2 | No |
Primary | Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL) | Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo. | Baseline, Day 3 | No |
Secondary | Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2 | Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo. | Baseline, Day 2 | No |
Secondary | Assay Sensitivity of Moxifloxacin at 1100h (2 Hour Post-administration of Moxifloxacin) on Day 2 | Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo. | Baseline, Day 2 | No |
Secondary | Assay Sensitivity of Moxifloxacin at 1200h (3 Hour Post-administration of Moxifloxacin) on Day 2 | Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo. | Baseline, Day 2 | No |
Secondary | Number of Subjects With QTcP Interval >450msec at Any Timepoint on Any Day in Exenatide and Placebo | Number of subjects with QTcP > 450 msec at any timepoint on any day was summarized by frequency for exenatide and placebo. | Day 1, 2, or 3 | No |
Secondary | Number of Subjects With Increase of QTcP Interval From Baseline >30msec at Any Timepoint on Any Day in Exenatide and Placebo | Number of subjects with increase of QTcP interval from baseline >30 msec at any timepoint on any day was summarized by frequency for exenatide and placebo. | Baseline, Day 1, 2, or 3 | No |
Secondary | Plasma Exenatide Concentrations at Steady State on Day 1, 2 and 3 | The plasma exenatide concentration at steady state was descriptively summarized by geometric mean, standard error, and its effect on placebo-adjusted change from baseline in QTcP was assessed. | Baseline, Day 1, 2, and 3 | No |
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