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NCT01460368 · ClinicalTrials.gov registry record · Phase 1
A Study on the Effects of LY2409021 on the Electrical Impulses of the Heart
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT01460368: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01460368 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01460368, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study 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.
Primary Outcome
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 part
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG LY2409021
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01460368 record still lists
NCT01460368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01460368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01460368 about?
NCT01460368 is a clinical study titled "A Study on the Effects of LY2409021 on the Electrical Impulses of the Heart". 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 tha...
What is the current status of trial NCT01460368?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2011-10. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01460368?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), LY2409021 (DRUG).
Who is sponsoring clinical trial NCT01460368?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01460368's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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