- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460368
A Study on the Effects of LY2409021 on the Electrical Impulses of the Heart
A Placebo- and Positive-Controlled Study of the Electrophysiological Effects of a Supratherapeutic Dose of LY2409021 in Healthy Subjects
Part A: The purpose of Part A of the study is to look at the electrocardiogram (ECG) effects due to blood sugar changes after a meal compared to when LY2409021 is also given with a meal.
Part B: The purpose of Part B is to evaluate the effect of LY2409021, when given at a dose level much higher than what would normally be given, on the electrical activity of the heart as measured by ECG in relation to placebo and moxifloxacin.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States
- 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.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- are overtly healthy males or females, as determined by medical history and physical examination
- female participants: women not of child-bearing potential due to surgical sterilization (hysterectomy alone or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history, or menopause Women with an intact uterus are deemed postmenopausal if they are >=45 years old, have not taken hormones or oral contraceptives within the last year, had cessation of menses for at least 1 year, or have had 6 to 12 months of amenorrhea with follicle-stimulating hormone levels consistent with postmenopausal state
- have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m^2), inclusive, at screening
- have a fasting blood glucose between 54 to 110 milligrams per deciliter (mg/dL) (3.0 to 6.1 millimoles per liter [mmol/L])
- have a clinically normal screening electrocardiogram (ECG) with a measurable QT interval as judged by central reader, which allows accurate measurements of QT interval
- have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- have venous access sufficient to allow for blood sampling
- are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- have normal blood pressure and pulse rate (supine) at screening, or with minor deviations judged to be acceptable by the investigator
- have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
- serum magnesium and potassium equal to or above the lower limit of normal
Exclusion Criteria:
- are currently enrolled in or have completed or discontinued within the last 30 days (from screening) from a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- have known allergies to LY2409021, related compounds or any components of the formulations, or to moxifloxacin
- are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2409021
- personal or family history of long QT syndrome
- family history of sudden unexplained death or cardiac death in a family member under 60 years of age
- personal history of unexplained syncope within the last year
- have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- show evidence of hepatitis C and/or positive hepatitis C antibody
- show evidence of hepatitis B and/or positive hepatitis B surface antigen
- are women with a positive pregnancy test or women who are lactating
- intend to use over-the-counter (including mineral supplements and herbal medicine) or prescription medication within 7 days prior to dosing
- have donated blood of more than 500 milliliters (mL) within the last month
- have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits), or are unwilling to comply with alcohol restrictions during the study (that is, refrain from alcohol consumption from 24 hours prior to dosing until the completion of each treatment period and to consume no more than 2 units of alcohol per day between treatment periods)
- are participants who smoke more than 10 cigarettes per day and/or are unable to abide by the study restrictions for smoking/tobacco use (that is, refrain from smoking for approximately 2 hours prior to each ECG timepoint or for a total of approximately 12 hours)
- are participants who are unable to abide by the study restrictions for caffeine/xanthine use (that is, refrain from consuming caffeine/xanthine containing drinks and foods [such as coffee, tea, cola, and chocolate] on days on which ECGs are performed, and maintain consistent consumption habits on all other days of the study)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Part A: LY2409021
Participants will receive 2 standard meals; one alone without LY2409021, and one along with a single dose of 300 milligrams (mg) LY2409021 administered orally.
Participants enrolled in Part A will not be allowed to participate in Part B.
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Administered orally
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Experimental: Part B: LY2409021
300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period.
The treatment and washout period was a total of 15 days in length.
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Administered orally
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Placebo Comparator: Part B: Placebo
Administered orally as a single dose on Day 1 of the relevant treatment period.
The treatment and washout period was a total of 15 days in length.
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Administered orally
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Active Comparator: Part B: Moxifloxacin
400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period.
The treatment and washout period was a total of 15 days in length.
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Administered orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (LY2409021)
Time Frame: Baseline, 2, 4, 6, 8, 12, and 24 hours
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The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33.
Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves.
Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.
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Baseline, 2, 4, 6, 8, 12, and 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (Moxifloxacin)
Time Frame: Baseline, 2 and 4 hours
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The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33.
Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves.
Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.
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Baseline, 2 and 4 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Moxifloxacin
Other Study ID Numbers
- 14149
- I1R-FW-GLBP (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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