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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.

A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects

IV Exenatide (therapeutic and supratherapeutic concentrations)

Research Site

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

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.

Age Continuous

Gender, Male/Female

Weight

Study Specific Characteristic

60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.

Evaluable Population included all ITT subjects who completed all ECG assessment periods and have valid ECG measurements and no vomiting in any ECG data extraction window. No missing value was imputed.

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 MMRM between exenatide and placebo.

Evaluable Population. No imputation for missing value was used.

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)

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)

Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.

Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.

Assay Sensitivity of Moxifloxacin at 1000h (1 hour Post-administration of Moxifloxacin) on Day 2

Assay Sensitivity of Moxifloxacin at 1100h (2 hour Post-administration of Moxifloxacin) on Day 2

Assay Sensitivity of Moxifloxacin at 1200h (3 hour Post-administration of Moxifloxacin) on Day 2

Number of subjects with QTcP > 450 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.

Number of Subjects With QTcP Interval >450msec 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.

Number of Subjects With Increase of QTcP Interval From Baseline >30msec at Any Timepoint on Any Day in Exenatide and Placebo

Day 1

Day 2

Day 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.

The analysis is to test the significance of the linear regression slope (null hypothesis: slope equal to zero) between placebo-adjusted change from baseline in QTcP and exenatide concentration.

Evaluable Population. No imputation for missing value was used. Day 1, 2, and 3 exenatide concentration < LLOQ was set to missing.

Arms	Assigned Interventions
Experimental: Exenatide	Drug: Exenatide IV Exenatide (therapeutic and supratherapeutic concentrations)
Placebo Comparator: Placebo	Drug: Placebo comparator IV Placebo (matching volume of placebo)
Active Comparator: Moxifloxacin	Drug: Moxifloxacin Oral Moxifloxacin (400 mg)

A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects

Official Title

Medical condition

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Healthy volunteers

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Verification:

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Documents available

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