Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-26 @ 12:10 PM
Study NCT ID:
NCT01460368
Status:
COMPLETED
Last Update Posted:
2019-01-07
First Post:
2011-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study on the Effects of LY2409021 on the Electrical Impulses of the Heart
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A Placebo- and Positive-Controlled Study of the Electrophysiological Effects of a Supratherapeutic Dose of LY2409021 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| I1R-FW-GLBP | OTHER | Eli Lilly and Company | View |