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A Study of LY2484595 on the Electrical Activity of the Heart

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01537887
Recruitment Status : Completed
First Posted : February 23, 2012
Results First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: LY2484595 Drug: Placebo Drug: Moxifloxacin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Placebo- and Positive-Controlled Study of the Effect of LY2484595 on QT Interval in Healthy Subjects
Study Start Date : February 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Placebo Comparator: Placebo
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
Administered orally once daily for 10 days.

Experimental: 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.
Drug: LY2484595
Administered orally once daily for 10 days.

Active Comparator: 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.
Drug: Moxifloxacin
Single dose administered orally.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2484595 During One Dosing Interval at Steady State [ Time Frame: Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose ]
  2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2484595 During One Dosing Interval at Steady State [ Time Frame: Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose ]
  3. Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins [ Time Frame: Baseline, Day 11 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537887


Locations
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United States, Florida
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, 32117
United States, Indiana
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, 47710
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01537887    
Other Study ID Numbers: 11947
I1V-MC-EIAK ( Other Identifier: Eli Lilly and Company )
First Posted: February 23, 2012    Key Record Dates
Results First Posted: March 7, 2019
Last Update Posted: March 7, 2019
Last Verified: November 2018
Additional relevant MeSH terms:
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Evacetrapib
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents