A Study of LY2484595 on the Electrical Activity of the Heart

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect on the electrical activity of the heart as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to 10 days of placebo in relation to a single dose of moxifloxacin. Information about any side effects that occur will also be collected.

Official Title
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A Placebo- and Positive-Controlled Study of the Effect of LY2484595 on QT Interval in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: LY2484595
* Drug: Placebo
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females Body mass index (BMI) of 18.5 to 29 kilograms per square meter (kg/m²) Reliable and willing to be available for the duration of the study and are willing to follow study procedures Provided written informed consent Exclusion Criteria: Known allergies to LY2484595 or moxifloxacin Personal or family history of long QT syndrome, heart failure, or low blood potassium (hypokalemia) a family history of sudden death, or unexplained syncope within the last year Positive findings on urinary drug screening Cigarette smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period. | Drug: Placebo<br>* Administered orally once daily for 10 days.<br>|
| Experimental: 1200 milligrams (mg) LY2484595<br>Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period. | Drug: LY2484595<br>* Administered orally once daily for 10 days.<br>|
| Active Comparator: 400 mg Moxifloxacin<br>Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods, separated by at least a 14-day washout period. | Drug: Moxifloxacin<br>* Single dose administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo | Data were collected using a 12-lead electrocardiogram (ECG). The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle and corrected for heart rate. Population-corrected QT interval (QTcP) formula: QTcP = QT / RR^ß, where ß is the population correction factor. | Predose of Day 1, Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2484595 During One Dosing Interval at Steady State |  | Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose | 
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2484595 During One Dosing Interval at Steady State |  | Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose | 
| Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins |  | Baseline, Day 11 |