A Study on the Effects of LY2409021 on the Electrical Impulses of the Heart

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01460368
First received: October 7, 2011
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2409021
Drug: Placebo
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Placebo- and Positive-Controlled Study of the Electrophysiological Effects of a Supratherapeutic Dose of LY2409021 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Part B: Mean Change in 12-lead electrocardiogram (ECG) corrected QT intervals of LY2409021 compared to placebo [ Time Frame: baseline, up to 24 hours post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 68
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: LY2409021
Participants will receive 2 standard meals; one alone without LY2409021, and one along with a single dose of LY2409021 300 mg administered orally. Participants enrolled in Part A will not be allowed to participate in Part B.
Drug: LY2409021
Administered orally
Placebo Comparator: Part B: Placebo
Administered orally as a single dose on Day 1 of the relevant treatment period. Each subsequent treatment period will begin approximately 15 days after dosing.
Drug: Placebo
Administered orally
Active Comparator: Part B: Moxifloxacin
Moxifloxacin 400 mg administered orally as a single dose on Day 1 of the relevant treatment period. Each subsequent treatment period will begin approximately 4-15 days after dosing.
Drug: Moxifloxacin
Administered orally
Experimental: Part B: LY2409021
LY2409021 300 mg administered orally as a single dose on Day 1 of the relevant treatment period. Each subsequent treatment period will begin approximately 15 days after dosing.
Drug: LY2409021
Administered orally

Detailed Description:

This is a 2 part study. Part A is a single-dose study to compare the effects of a meal on glucose, insulin and QT in healthy participants with and without LY2409021. Part B of this study is a randomized, 3-period, crossover design, in which participants and investigators are blinded to placebo and LY2409021, and will assess the electrophysiological effects of a single supratherapeutic dose of LY2409021 compared to a positive control (moxifloxacin) and placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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, who have not taken hormones or oral contraceptives within the last year, and had cessation of menses for at least 1 year, or who 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 kg/m^2, inclusive, at screening
  • have a fasting blood glucose between 54 to 110 mg/dL (3.0 to 6.1 mmol/L)
  • have a clinically normal screening 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 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460368

Locations
United States, Texas
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.
Dallas, Texas, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01460368     History of Changes
Other Study ID Numbers: 14149, I1R-FW-GLBP
Study First Received: October 7, 2011
Last Updated: March 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014