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NCT01250873 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of the Coadministration of LY2216684 With Sertraline
A Phase 1 study of Major Depressive Disorder, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01250873: Completed Phase 1 study of Major Depressive Disorder, sponsored by Eli Lilly and Company.
NCT01250873 is a Phase 1 study of Major Depressive Disorder that has completed, run by Eli Lilly and Company. The registered enrollment target is 20 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01250873, a Phase 1 study of Major Depressive Disorder, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
LY2216684 is being studied as adjunctive treatment for major depressive disorder (MDD) in participants who are partial responders to selective serotonin reuptake inhibitors (SSRIs). Sertraline is a medication that is widely used to treat MDD and is a known substrate of cytochrome P450s (CYP450s), including CYP450 2D6 (CYP2D6), CYP450 2C19 (CYP2C19), CYPP450 3A4 (CYP3A4), and a modest inhibitor of CYP2D6. Based on the diversity of hepatic metabolic clearance pathways for LY2216684 and its elimination by the kidney, it is expected that CYP2D6 inhibition by sertraline will not result in a substantial change in the pharmacokinetic (PK) profile of LY2216684. LY2216684 is only known to be a moderate inhibitor of CYP2C19, so it is unlikely that coadministration of sertraline with LY2216684 will result in a clinically meaningful change in the PK of sertraline. This study is being conducted to test these hypotheses.
Primary Outcome
The Least Squares (LS) geometric mean AUCτ of LY2216684 was calculated based on the LY2216684 plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau \[τ\]) when LY221684 was administered alone (Day 3) and when LY2216684 was coadministered with sertraline (Day 13). The Day 13-to-Day 3 ratio of the LY2216684 LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated.
Conditions Studied
Interventions
- DRUG Sertraline
- 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 | 20 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
What the finished NCT01250873 record still lists
NCT01250873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sertraline is the first listed.
NCT01250873 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01250873 about?
NCT01250873 is a clinical study titled "A Pharmacokinetic Study of the Coadministration of LY2216684 With Sertraline". LY2216684 is being studied as adjunctive treatment for major depressive disorder (MDD) in participants who are partial responders to selective serotonin reuptake inhibitors (SSRIs). Sertraline is a medication that is widely used to treat MDD and is a known substrate of cytochrome P450s (CYP450s), in...
What is the current status of trial NCT01250873?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-11. Estimated completion is 2011-01.
What conditions does trial NCT01250873 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT01250873?
The interventions under investigation include: Sertraline (DRUG), LY2216684 (DRUG).
Who is sponsoring clinical trial NCT01250873?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01250873 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
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Where NCT01250873's enrollment target sits among peer trials
20 243rd of 282 higher than 34 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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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