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NCT01389765 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Food on LY2216684
A Phase 1 study of Depressive Disorder, Major, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01389765: Completed Phase 1 study of Depressive Disorder, Major, sponsored by Eli Lilly and Company.
NCT01389765 is a Phase 1 study of Depressive Disorder, Major that has completed, run by Eli Lilly and Company. The registered enrollment target is 24 participants, below the 242-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01389765, a Phase 1 study of Depressive Disorder, Major, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the effect of food on LY2216684. There will be 2 study periods each lasting up to 5 days. There will be at least 7 days between the two doses and a follow up will occur at least 7 days after the last dose. Screening is required within 30 days prior to the start of the study.
Primary Outcome
The AUC for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.
Conditions Studied
Interventions
- DRUG LY2216684
Study Locations (1)
Florida
- 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. - Daytona Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT01389765 record still lists
NCT01389765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 242-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 1 intervention - of which LY2216684 is the first listed.
NCT01389765 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01389765 about?
NCT01389765 is a clinical study titled "A Study to Evaluate the Effect of Food on LY2216684". This study will evaluate the effect of food on LY2216684. There will be 2 study periods each lasting up to 5 days. There will be at least 7 days between the two doses and a follow up will occur at least 7 days after the last dose. Screening is required within 30 days prior to the start of the study.
What is the current status of trial NCT01389765?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-07. Estimated completion is 2011-08.
What conditions does trial NCT01389765 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT01389765?
The interventions under investigation include: LY2216684 (DRUG).
Who is sponsoring clinical trial NCT01389765?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01389765 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Major
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01389765's enrollment target sits among peer trials
24 45th of 52 higher than 7 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major 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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