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

NCT01460368 | Completed Phase 1 Results

• 2 other identifiers: 14149I1R-FW-GLBP
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (LY2409021)

  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.

  Baseline, 2, 4, 6, 8, 12, and 24 hours

Secondary Outcomes (1)

• Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (Moxifloxacin)

  Baseline, 2 and 4 hours

Study Arms (4)

Part A: LY2409021

EXPERIMENTAL

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.

Drug: LY2409021

Part B: LY2409021

EXPERIMENTAL

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.

Drug: LY2409021

Part B: Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Part B: Moxifloxacin

ACTIVE COMPARATOR

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.

Drug: Moxifloxacin

Interventions

LY2409021 DRUG

Administered orally

Part A: LY2409021; Part B: LY2409021

Placebo DRUG

Administered orally

Part B: Placebo

Moxifloxacin DRUG

Administered orally

Part B: Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

adomeglivant; Moxifloxacin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic 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: October 7, 2011
• First Posted: October 26, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 7, 2019
• Results First Posted: October 18, 2018

Record last verified: 2018-12

Locations

US (1)