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NCT01389752 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Activated Charcoal on the Absorption of LY2216684 in Healthy Subjects
A Phase 1 study of Depressive Disorder, Major, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT01389752: Completed Phase 1 study of Depressive Disorder, Major, sponsored by Eli Lilly and Company.
NCT01389752 is a Phase 1 study of Depressive Disorder, Major that has completed, run by Eli Lilly and Company. The registered enrollment target is 22 participants, below the 242-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01389752, a Phase 1 study of Depressive Disorder, Major, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2 occasions, once with activated charcoal and once without activated charcoal. The study will evaluate the effect of charcoal on the absorption of LY2216684. Side effects will be documented. 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 AUC0-∞ of LY2216684 was measured. The AUC was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). 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
- DRUG Activated Charcoal
Study Locations (1)
Texas
- 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
What the finished NCT01389752 record still lists
NCT01389752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 242-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions - of which LY2216684 is the first listed.
NCT01389752 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01389752 about?
NCT01389752 is a clinical study titled "A Study to Evaluate the Effect of Activated Charcoal on the Absorption of LY2216684 in Healthy Subjects". The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2 occasions, once with activated charcoal and once without activated charcoal. The study will evaluate the effect of charcoal on the absorption of LY2216684. Side effects will be documented. There will be 2 study pe...
What is the current status of trial NCT01389752?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-07. Estimated completion is 2011-09.
What conditions does trial NCT01389752 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT01389752?
The interventions under investigation include: LY2216684 (DRUG), Activated Charcoal (DRUG).
Who is sponsoring clinical trial NCT01389752?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01389752 being conducted?
This trial has 1 study location across Texas. 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 NCT01389752's enrollment target sits among peer trials
22 47th of 52 higher than 6 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.
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