A Study of LY2484595 on the Electrical Activity of the Heart

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: LY2484595; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01537887

11947

I1V-MC-EIAK (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

1200 milligrams (mg) LY2484595

Experimental group

Description:

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

Treatment:

Drug: LY2484595

400 mg Moxifloxacin

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin