Phase 1 N=72 Randomized Double-blind Basic Science

A Study of LY2484595 on the Electrical Activity of the Heart

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT01537887 ↗

Enrolled (actual)

Serious AEs

0.5%

Results posted

Mar 2019

Primary outcome: Primary: Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo — -2.7; -4.6; -2.0; -1.1 milliseconds (msec)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: LY2484595 (Drug); Placebo (Drug); Moxifloxacin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo	-2.7; -4.6; -2.0; -1.1	—
SECONDARY Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2484595 During One Dosing Interval at Steady State	5270	—
SECONDARY Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2484595 During One Dosing Interval at Steady State	48300	—
SECONDARY Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins	-8; 112; 9; -35; -9; 32	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01537887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.