A Placebo- and Positive-Controlled Study of the Effect of LY2484595 on QT Interval in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Volunteers
- Sponsor
- Eli Lilly and Company
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo
Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period.
Intervention: Placebo
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.
Intervention: LY2484595
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.
Intervention: Moxifloxacin
Outcomes
Primary Outcomes
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
- 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)