NCT01537887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

March 7, 2019

Completed
Last Updated

March 7, 2019

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

February 17, 2012

Results QC Date

February 18, 2018

Last Update Submit

November 9, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period.

Drug: Placebo

1200 milligrams (mg) LY2484595

EXPERIMENTAL

Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period.

Drug: LY2484595

400 mg Moxifloxacin

ACTIVE COMPARATOR

Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods, separated by at least a 14-day washout period.

Drug: Moxifloxacin

Interventions

LY2484595DRUG

Administered orally once daily for 10 days.

1200 milligrams (mg) LY2484595
PlaceboDRUG

Administered orally once daily for 10 days.

Placebo
MoxifloxacinDRUG

Single dose administered orally.

400 mg Moxifloxacin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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, 32117, United States

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.

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Interventions

evacetrapibMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 23, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 7, 2019

Results First Posted

March 7, 2019

Record last verified: 2018-11

Locations

US(2)