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| ID | Type | Description | Link |
|---|---|---|---|
| H9P-EW-LNCM | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2216684 | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2216684 | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 72 hours after administration of study drug |
| Pharmacokinetics: Maximum Concentration (Cmax) | Up to 72 hours after administration of study drug | |
| Pharmacokinetics: Time to Maximum Concentration (Tmax) | Up to 72 hours after administration of study drug |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | Florida | 33014 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Hepatic Function | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function |
| FG001 | Mild Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A) |
| FG002 | Moderate Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B) |
| FG003 | Severe Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Hepatic Function | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function |
| BG001 | Mild Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours times nanograms/milliliter | Up to 72 hours after administration of study drug |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Hepatic Function | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C568831 | alpha-((5-fluoro-2-methoxyphenyl)methyl)-alpha-(tetrahydro-2H-pyran-4-yl)-2-morpholinemethanol |
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| United States |
| 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 | Florida | 32809 | United States |
| 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 | Texas | 78215 | United States |
| BG002 | Moderate Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B) |
| BG003 | Severe Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C) |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Moderate Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B) |
| OG003 | Severe Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C) |
|
|
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) | Participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter | Up to 72 hours after administration of study drug |
|
|
|
| Primary | Pharmacokinetics: Time to Maximum Concentration (Tmax) | Participants who received at least one dose of study drug. | Posted | Median | Full Range | hours | Up to 72 hours after administration of study drug |
|
|
|
| 0 |
| 12 |
| 6 |
| 12 |
| EG001 | Mild Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with mild hepatic impairment (Child-Pugh A) | 0 | 8 | 3 | 8 |
| EG002 | Moderate Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with moderate hepatic impairment (Child-Pugh B) | 0 | 8 | 6 | 8 |
| EG003 | Severe Hepatic Impairment | LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with severe hepatic impairment (Child-Pugh C) | 0 | 8 | 5 | 8 |
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
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| Urinary hesitation | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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