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| ID | Type | Description | Link |
|---|---|---|---|
| H9P-EW-LNDC | Other Identifier | Eli Lilly and Company |
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This study will evaluate the effect of food on LY2216684. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2216684 administered in fasted then fed state | Experimental | Period 1: Single 18-mg (milligram) oral dose of LY2216684 administered in fasted state. Period 2: Single 18-mg oral dose of LY2216684 administered in fed state. Periods will be separated by a minimum of 7 days. |
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| LY2216684 administered in fed then fasted state | Experimental | Period 1: Single 18-mg oral dose of LY2216684 administered in fed state. Period 2: Single 18-mg oral dose of LY2216684 administered in fasted state. Periods will be separated by a minimum of 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2216684 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684 | The AUC for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC. | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684 | The Cmax for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric LS means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax. | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose |
| Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684 | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose |
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Inclusion Criteria:
Male subjects: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
Female subjects: Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 4 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or women not of child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause [at least 1 year without menses or 6 months without menses and a follicle stimulating hormone (FSH) >40 mIU/mL (milli-international-units/milliliter)]
All Subjects:
Exclusion Criteria:
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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. | Daytona Beach | Florida | 32117 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2216684 During Fed, Then LY2216684 During Fasting State | In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in fed state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the fasting state. Periods were separated by a 7-day washout period. |
| FG001 | LY2216684 During Fasting, Then LY2216684 During Fed State | In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in fasting state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the fed state. Periods were separated by a 7-day washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Day 1) |
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| Washout Period (7 Days) |
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| Second Intervention (Day 1) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in either fasted or fed state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the alternative feeding state that was not used during Period 1 (fasted or fed). Periods were separated by a 7-day washout period. |
| Units | Counts |
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| Participants |
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| 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 Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684 | The AUC for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC. | All participants with a baseline observation and at least 1 post-baseline observation. | Posted | Least Squares Mean | 90% Confidence Interval | nanogram*hour/milliliter (ng*h/mL) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose |
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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 | LY2216684 Administered in Fed State | Participants received a single oral dose of 18 mg LY2216684 in fed state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 14.0 | 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 |
| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| LY2216684 Administered in Fasted State |
Participants received a single oral dose of 18 mg LY2216684 in fasted state. |
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| Primary | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684 | The Cmax for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric LS means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax. | All participants with a baseline observation and at least 1 post-baseline observation. | Posted | Least Squares Mean | 90% Confidence Interval | nanogram/milliliter (ng/mL) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose |
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| Primary | Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684 | All participants with a baseline observation and at least 1 post-baseline observation. | Posted | Median | Full Range | hours | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose |
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| 0 |
| 24 |
| 7 |
| 24 |
| EG001 | LY2216684 Administered in Fasted State | Participants received a single oral dose of 18 mg LY2216684 in fasted state. | 0 | 24 | 6 | 24 |
| Tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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