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NCT01241435 · ClinicalTrials.gov registry record · Phase 1
A Study of LY2216684 in Participants With Impaired Hepatic Function
A Phase 1 study of Depressive Disorder, Major, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 3
- Study locations
NCT01241435 is a Phase 1 study of Depressive Disorder, Major that has completed, run by Eli Lilly and Company. The registered enrollment target is 36 participants, below the 242-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT01241435, a Phase 1 study of Depressive Disorder, Major, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the effect of liver function on how much of the study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The duration of participation in this study is approximately 12 days, not including the screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1 out-patient follow-up visit. A screening visit is required within 30 days prior to the start of the study. This research study will be an open-label study. The study involves a single oral dose of 18 milligrams (mg) LY2216684 given as 2 tablets.
Conditions Studied
Interventions
- DRUG LY2216684
Study Locations (3)
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. - Miami
- 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. - Orlando
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. - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01241435
The ClinicalTrials.gov registry entry for NCT01241435 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (85% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
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.
NCT01241435 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT01241435 about?
NCT01241435 is a clinical study titled "A Study of LY2216684 in Participants With Impaired Hepatic Function". The purpose of this study is to evaluate the effect of liver function on how much of the study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The duration of participation in this...
What is the current status of trial NCT01241435?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2010-10. Estimated completion is 2011-04.
What conditions does trial NCT01241435 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT01241435?
The interventions under investigation include: LY2216684 (DRUG).
Who is sponsoring clinical trial NCT01241435?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01241435 being conducted?
This trial has 3 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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