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| ID | Type | Description | Link |
|---|---|---|---|
| H9P-EW-LNCH | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure if there is any difference in how the body breaks down or inactivates either fluoxetine or LY2216684 when both of these medicines are given together. This study will look at how fluoxetine might affect LY2216684 and how giving LY2216684 might affect fluoxetine in the body.
The duration of study participation in this study is approximately 36 days not including the screening appointment. This study requires 1 research unit confinement of 29 days/28 nights followed by 1 outpatient appointment. A screening appointment is required within 30 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2216684 + fluoxetine | Experimental | LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1, 2, and 3 and Days 25-27 Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2216684 | Drug | LY2216684: 18 mg po QD on Days 1, 2, and 3 and Days 25-27 |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684 | 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 LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated. | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27 |
| Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of LY2216684 | The Least Squares (LS) geometric mean Cmax of LY2216684 was determined when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated. | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27 |
| Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of LY2216684 | Tmax of LY2216684 was determined using the median of paired differences between the 2 treatment groups when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The 90% confidence interval (CI) for the median of differences was calculated. | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time-Curve Over a 24-Hour Dosing Interval (AUCτ) of Fluoxetine and Norfluoxetine | The Least Squares (LS) geometric means AUCτ of fluoxetine and norfluoxetine were calculated based on the fluoxetine and norfluoxetine plasma concentration time curves from time 0 hour (hr) to time 24 hr (tau [τ]) when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY22166684 (Day 27). The Day 27-to-Day 24 ratios of fluoxetine and norfluoxetine LS geometric means of AUCτ and the associated 90% confidence interval (CI) of the ratios were calculated. |
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Inclusion Criteria:
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 | Evansville | Indiana |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2216684 + Fluoxetine | LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27. Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fluoxetine |
| Drug |
Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27) |
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| Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27 |
| Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Fluoxetine and Norfluoxetine | The Least Squares (LS) geometric means Cmax of fluoxetine and norfluoxetine were determined when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY2216684 (Day 27). The Day 27-to-Day 24 ratios of fluoxetine and norfluoxetine LS geometric means of Cmax and the associated 90% confidence interval (CI) of the ratios were calculated. | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27 |
| Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of Fluoxetine and Norfluoxetine | Tmax of fluoxetine and norfluoxetine was determined using the median of paired differences between the 2 treatment groups when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY2216684 (Day 27). The 90% confidence interval (CI) for the median of differences was calculated. | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27 |
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2216684 + Fluoxetine | LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27. Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27). |
| 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 | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | 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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| 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 | Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684 | 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 LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated. | The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment. | Posted | Least Squares Mean | 90% Confidence Interval | hour*nanogram per milliliter (h*ng/mL) | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27 |
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| Primary | Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of LY2216684 | The Least Squares (LS) geometric mean Cmax of LY2216684 was determined when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated. | The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment. | Posted | Least Squares Mean | 90% Confidence Interval | nanogram per milliliter (ng/mL) | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27 |
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| Primary | Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of LY2216684 | Tmax of LY2216684 was determined using the median of paired differences between the 2 treatment groups when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The 90% confidence interval (CI) for the median of differences was calculated. | The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment. | Posted | Median | 90% Confidence Interval | hours | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27 |
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| Secondary | Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time-Curve Over a 24-Hour Dosing Interval (AUCτ) of Fluoxetine and Norfluoxetine | The Least Squares (LS) geometric means AUCτ of fluoxetine and norfluoxetine were calculated based on the fluoxetine and norfluoxetine plasma concentration time curves from time 0 hour (hr) to time 24 hr (tau [τ]) when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY22166684 (Day 27). The Day 27-to-Day 24 ratios of fluoxetine and norfluoxetine LS geometric means of AUCτ and the associated 90% confidence interval (CI) of the ratios were calculated. | The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment. | Posted | Least Squares Mean | 90% Confidence Interval | hour*nanogram per milliliter (h*ng/mL) | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27 |
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| Secondary | Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Fluoxetine and Norfluoxetine | The Least Squares (LS) geometric means Cmax of fluoxetine and norfluoxetine were determined when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY2216684 (Day 27). The Day 27-to-Day 24 ratios of fluoxetine and norfluoxetine LS geometric means of Cmax and the associated 90% confidence interval (CI) of the ratios were calculated. | The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment. | Posted | Least Squares Mean | 90% Confidence Interval | nanogram per milliliter (ng/mL) | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27 |
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| Secondary | Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of Fluoxetine and Norfluoxetine | Tmax of fluoxetine and norfluoxetine was determined using the median of paired differences between the 2 treatment groups when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY2216684 (Day 27). The 90% confidence interval (CI) for the median of differences was calculated. | The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment. | Posted | Median | 90% Confidence Interval | hours | Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27 |
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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 | LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27. | 0 | 20 | 16 | 20 | ||
| EG001 | Fluoxetine | Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27). | 0 | 20 | 13 | 20 | ||
| EG002 | LY2216684 + Fluoxetine | LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27. Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27). | 0 | 20 | 14 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Defaecation urgency | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Catheter site inflammation | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Feeling jittery | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Urinary hesitation | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| 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 |
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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