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NCT01536951 · ClinicalTrials.gov registry record · Phase 1
A Study of LY3009104 in Healthy Participants
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT01536951: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01536951 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01536951, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
This will be a 2-part, randomized, participant- and investigator-blind study in healthy males and females. Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that yields drug exposures slightly exceeding typical exposures anticipated from repeated administration of an efficacious dose to participants. The concentration of the drug in the blood stream will be measured and information about any side effects that may occur will also be collected. Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral dose.
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 is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR\^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta\*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all
Interventions
- DRUG Placebo
- DRUG moxifloxacin
- DRUG LY3009104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01536951 record still lists
NCT01536951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01536951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01536951 about?
NCT01536951 is a clinical study titled "A Study of LY3009104 in Healthy Participants". This will be a 2-part, randomized, participant- and investigator-blind study in healthy males and females. Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that yields drug exposures slightly exceeding typical exposures anticipated from repeated administration...
What is the current status of trial NCT01536951?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2012-02. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01536951?
The interventions under investigation include: Placebo (DRUG), moxifloxacin (DRUG), LY3009104 (DRUG).
Who is sponsoring clinical trial NCT01536951?
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 NCT01536951's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 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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