A Study of LY2484595 on the Electrical Activity of the Heart

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537887
• Other study ID #: 11947
• Secondary ID: I1V-MC-EIAK
• Status: Completed
• Phase: Phase 1
• Start date: February 2012
• Est. completion date: June 2012

Study information

• Verified date: November 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2484595
Administered orally once daily for 10 days.
• Placebo
Administered orally once daily for 10 days.
• Moxifloxacin
Single dose administered orally.

Locations

Country	Name	City	State
United States	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	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.	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins		Baseline, Day 11