A Study of LY2484595 on the Electrical Activity of the Heart

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: LY2484595; Drug: Moxifloxacin

• Registration Number: NCT01537887
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-23
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2018-02-18
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-09
• Last Update Submitted: 2018-11-09
• Results First Posted: 2019-03-07
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period.
1200 milligrams (mg) LY2484595	LY2484595	Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period.
400 mg Moxifloxacin	Moxifloxacin	Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods, separated by at least a 14-day washout period.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo	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 Outcome Measures

Name	Time	Method
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
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
Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins	Baseline, Day 11

Trial Locations

Locations (1)

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, United States