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| ID | Type | Description | Link |
|---|---|---|---|
| I1R-FW-GLBP | Other Identifier | Eli Lilly and Company |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2409021 | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (Moxifloxacin) | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: LY2409021 | Participants received 2 standard meals; one alone without LY2409021, and one along with a single dose of 300 milligrams (mg) LY2409021 administered orally to determine the effects of a meal on electrocardiogram (ECG) activity. Participants enrolled in Part A were not allowed to participate in Part B. |
| FG001 | Part B: LY2409021, Placebo, Moxifloxacin | Period 1: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1. Period 2: Placebo administered orally as a single dose on Day 1. Period 3: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1. |
| FG002 | Part B: Moxifloxacin, LY2409021, Placebo | Period 1: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1. Period 2: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1. Period 3: Placebo administered orally as a single dose on Day 1. |
| FG003 | Part B: Placebo, Moxifloxacin, LY2409021 | Period 1: Placebo administered orally as a single dose on Day 1. Period 2: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1. Period 3: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1. |
| FG004 | Part B: Moxifloxacin, Placebo, LY2409021 | Period 1: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1. Period 2: Placebo administered orally as a single dose on Day 1. Period 3: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1. |
| FG005 | Part B: Placebo, LY2409021, Moxifloxacin | Period 1: Placebo administered orally as a single dose on Day 1. Period 2: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1. Period 3: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1. |
| FG006 | Part B: LY2409021, Moxifloxacin, Placebo | Period 1: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1. Period 2: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1. Period 3: Placebo administered orally as a single dose on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A |
| ||||||||||||||||
| Part B: First Intervention (Period 1) |
| ||||||||||||||||
| Part B: Washout (up to 15 Days) |
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| Part B: Second Intervention (Period 2) |
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| Part B: Washout (up to 15 Days) |
| ||||||||||||||||
| Part B: Third Interventions (Period 3) |
|
All participants who received at least 1 dose of study drug (Part A or Part B).
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A | A single dose of 300 milligrams (mg) LY2409021 administered orally on Day 1. Participants enrolled in Part A were not allowed to participate in Part B. |
| BG001 | Part B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who received at least 1 dose of LY2409021 or Placebo with evaluable Fridericia Correction Formula (QTcF) data. | Posted | Least Squares Mean | 90% Confidence Interval | milliseconds | Baseline, 2, 4, 6, 8, 12, and 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: LY2409021 | A single dose of 300 milligrams (mg) LY2409021 administered orally on Day 1. Participants enrolled in Part A were not allowed to participate in Part B. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid oedema | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000601762 | adomeglivant |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo |
| Drug |
Administered orally |
|
| Moxifloxacin | Drug | Administered orally |
|
| Baseline, 2 and 4 hours |
| United States |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants received a single dose of either 300 milligrams (mg) LY2409021, 400 mg Moxifloxacin, or Placebo on Day 1 in 1 of 3 Study Periods so that after the completion of the 3 study periods, each participant received a single dose of each drug.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period. |
| OG001 | Part B: Placebo | Placebo: Administered orally as a single dose on Day 1 of the relevant treatment period. |
|
|
|
| Secondary | Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (Moxifloxacin) | 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. | Participants who received at least 1 dose of Moxifloxacin or Placebo with evaluable QTcF data. | Posted | Least Squares Mean | 90% Confidence Interval | milliseconds | Baseline, 2 and 4 hours |
|
|
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Part B: Placebo | Administered orally as a single dose on Day 1 of the relevant treatment period. | 0 | 57 | 12 | 57 |
| EG002 | Part B: Moxifloxacin | 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period. | 0 | 58 | 11 | 58 |
| EG003 | Part B: LY2409021 | 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period. | 0 | 59 | 9 | 59 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Application site rash | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Application site reaction | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hangnail | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 4 hours postdose |
|
|
| Least Squares Mean Difference |
| 10.56 |
| 2-Sided |
| 90 |
| 7.69 |
| 13.43 |
Treatment comparison at 4 hours. |
| Superiority or Other |