A Study of LY2484595 on the Electrical Activity of the Heart

Eli Lilly and Company72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

LY2484595DRUG

Administered orally once daily for 10 days.

PlaceboDRUG

Administered orally once daily for 10 days.

MoxifloxacinDRUG

Single dose administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Daytona Beach, Florida, United States

Evansville, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: Predose of Day 1, Day 10

Secondary Outcomes

Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2484595 During One Dosing Interval at Steady State

Time frame: 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

Time frame: 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

Time frame: Baseline, Day 11

Data from ClinicalTrials.gov

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