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Completed

NCT Number: NCT01537887

A Study of LY2484595 on the Electrical Activity of the Heart

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2484595

Drug

Administered orally once daily for 10 days.

Placebo

Drug

Administered orally once daily for 10 days.

moxifloxacin

Drug

Single dose administered orally.

Primary outcomes

  1. Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo

    Time frame: Predose of Day 1, Day 10

    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.

Secondary outcomes

  1. 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

  2. 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

  3. Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins

    Time frame: Baseline, Day 11

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 23, 2012
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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