A Study of LY2484595 on the Electrical Activity of the Heart

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-06-30

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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally once daily for 10 days.

1200 milligrams (mg) LY2484595

Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period.

Group Type EXPERIMENTAL

LY2484595

Intervention Type DRUG

Administered orally once daily for 10 days.

400 mg Moxifloxacin

Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods, separated by at least a 14-day washout period.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Single dose administered orally.

Interventions

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LY2484595

Administered orally once daily for 10 days.

Intervention Type DRUG

Placebo

Administered orally once daily for 10 days.

Intervention Type DRUG

Moxifloxacin

Single dose administered orally.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes