A Phase 1 interventional study of LY2216684 in Depressive Disorder, Major, sponsored by Eli Lilly and Company. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-22.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Control Participants (Participants with Normal Hepatic Function):
Participants with Mild, Moderate, or Severe Hepatic Impairment:
Exclusion Criteria:
All Participants:
Control Participants (Participants with Normal Hepatic Function):
Participants with Mild, Moderate, or Severe Hepatic Impairment:
LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function, mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), or severe hepatic impairment (Child-Pugh C)
Drug: LY2216684
Administered orally
Also known as: Edivoxetine
Pharmacokinetics: Area Under the Concentration Curve (AUC)
The area under the plasma concentration versus time curve from 0 hours to infinity (AUC \[0-∞\]) for LY2216684 is presented.
Time frame: Up to 72 hours after administration of study drug
Pharmacokinetics: Maximum Concentration (Cmax)
Time frame: Up to 72 hours after administration of study drug
Pharmacokinetics: Time to Maximum Concentration (Tmax)
Time frame: Up to 72 hours after administration of study drug
| Milestone | Normal Hepatic Function | Mild Hepatic Impairment | Moderate Hepatic Impairment | Severe Hepatic Impairment |
|---|---|---|---|---|
| Started | 12 | 8 | 8 | 8 |
| Received at least 1 dose of study drug | 12 | 8 | 8 | 8 |
| Completed | 12 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 |
The area under the plasma concentration versus time curve from 0 hours to infinity (AUC \[0-∞\]) for LY2216684 is presented.
| hours times nanograms/milliliter | Normal Hepatic Function | Mild Hepatic Impairment | Moderate Hepatic Impairment | Severe Hepatic Impairment |
|---|---|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) | 601 ± 32 | 742 ± 52 | 961 ± 45 | 1020 ± 16 |
| nanograms/milliliter | Normal Hepatic Function | Mild Hepatic Impairment | Moderate Hepatic Impairment | Severe Hepatic Impairment |
|---|---|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) | 46.8 ± 27 | 39.6 ± 28 | 41.9 ± 33 | 34.7 ± 15 |
| hours | Normal Hepatic Function | Mild Hepatic Impairment | Moderate Hepatic Impairment | Severe Hepatic Impairment |
|---|---|---|---|---|
| Pharmacokinetics: Time to Maximum Concentration (Tmax) | 3.00 (1.00 to 5.00) | 3.50 (2.00 to 6.00) | 3.50 (1.00 to 5.00) | 3.50 (2.00 to 5.00) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Normal Hepatic Function | — | 0/12 (0%) | 6/12 (50%) |
| Mild Hepatic Impairment | — | 0/8 (0%) | 3/8 (37.5%) |
| Moderate Hepatic Impairment | — | 0/8 (0%) | 6/8 (75%) |
| Severe Hepatic Impairment | — | 0/8 (0%) | 5/8 (62.5%) |
| Event | Normal Hepatic Function | Mild Hepatic Impairment | Moderate Hepatic Impairment | Severe Hepatic Impairment |
|---|---|---|---|---|
| PalpitationsCardiac disorders | 0/12 | 0/8 | 0/8 | 2/8 |
| TinnitusEar and labyrinth disorders | 0/12 | 0/8 | 1/8 | 2/8 |
| ConstipationGastrointestinal disorders | 0/12 | 0/8 | 0/8 | 2/8 |
| DizzinessNervous system disorders | 3/12 | 0/8 | 1/8 | 2/8 |
| HeadacheNervous system disorders | 0/12 | 1/8 | 1/8 | 2/8 |
| NauseaGastrointestinal disorders | 2/12 | 0/8 | 1/8 | 0/8 |
| BlepharitisEye disorders | 0/12 | 0/8 | 1/8 | 0/8 |
| Vision blurredEye disorders | 0/12 | 0/8 | 0/8 | 1/8 |
| Abdominal discomfortGastrointestinal disorders | 0/12 | 1/8 | 0/8 | 0/8 |
| Dry mouthGastrointestinal disorders | 0/12 | 0/8 | 0/8 | 1/8 |
Participants who received at least one dose of study drug.
| Age, Continuous(years) | Normal Hepatic Function | Mild Hepatic Impairment | Moderate Hepatic Impairment | Severe Hepatic Impairment | Total |
|---|---|---|---|---|---|
| Mean | 49.5 ± 6.3 | 55.0 ± 4.9 | 54.5 ± 5.6 | 51.4 ± 6.9 | 52.3 ± 6.2 |
| Sex: Female, Male(Participants) | Normal Hepatic Function | Mild Hepatic Impairment | Moderate Hepatic Impairment | Severe Hepatic Impairment | Total |
|---|---|---|---|---|---|
| Female | 4 | 3 | 2 | 1 | 10 |
| Male | 8 | 5 | 6 | 7 | 26 |
| Race/Ethnicity, Customized(Participants) | Normal Hepatic Function | Mild Hepatic Impairment | Moderate Hepatic Impairment | Severe Hepatic Impairment | Total |
|---|---|---|---|---|---|
| White | 10 | 8 | 8 | 8 | 34 |
| Black/African American | 1 | 0 | 0 | 0 | 1 |
| Multiple | 1 | 0 | 0 | 0 | 1 |
| Region of Enrollment(Participants) | Normal Hepatic Function | Mild Hepatic Impairment | Moderate Hepatic Impairment | Severe Hepatic Impairment | Total |
|---|---|---|---|---|---|
| United States | 12 | 8 | 8 | 8 | 36 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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