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| ID | Type | Description | Link |
|---|---|---|---|
| H9P-EW-LNCU | Other Identifier | Eli Lilly and Company |
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The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2 occasions, once with activated charcoal and once without activated charcoal.
The study will evaluate the effect of charcoal on the absorption of LY2216684. Side effects will be documented. 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 without Charcoal, then with Charcoal | Experimental | Period 1: Single 18-mg (milligram) (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal. Periods will be separated by a minimum of 7 days. |
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| LY2216684 with Charcoal, then without Charcoal | Experimental | Period 1: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg of Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684 | The AUC0-∞ of LY2216684 was measured. The AUC was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC. | Predose, up to 72 hours after administration of study drug |
| Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 | The Cmax of LY2216684 was assessed. The Cmax was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric LSMeans were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax. | Predose, up to 72 hours after administration of study drug |
| Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684 | The tmax for LY2216684 was assessed. | Predose, up to 72 hours after administration of study drug |
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Inclusion Criteria:
Are overtly healthy, as determined by medical history and physical examination
- Male subjects: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of the 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 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 or 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])
Have a body weight >50 kg
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow for blood sampling as per the protocol
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site
Have normal blood pressure (BP) and pulse rate (sitting position)
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. | Dallas | Texas | 75247 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2216684 Without Charcoal, Then With Charcoal | Period 1: Single 18-mg (milligram) (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal. Periods will be separated by a minimum of 7 days. |
| FG001 | LY2216684 With Charcoal, Then Without Charcoal | Period 1: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg of Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Periods will be separated by a minimum of 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Period 1 |
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| Study Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | During Study Period 1, participants received a single oral dose of 18 mg LY2216684 alone or in combination with 1 g/kg Activated Charcoal 1 hour after LY2216684 administration. After at least 7 days, participants who initially received 18 mg LY2216684 alone received another single oral dose of 18 mg LY2216684 in combination with 1 g/kg Activated Charcoal 1 hour after LY2216684 administration during Study Period 2; participants who initially received 18 mg LY2216684 in combination with 1 g/kg Activated Charcoal received another single oral dose of 18 mg LY2216684 alone during Study Period 2. |
| Units | Counts |
|---|---|
| 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 AUC0-∞ of LY2216684 was measured. The AUC was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC. | All participants who were randomized, for whom AUC0-∞ data were available, and who were not excluded due to vomiting within twice the median time to maximum plasma concentration (tmax) of LY2216684. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | nanogram*hour/milliliter (ng*h/mL) | Predose, 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 | LY2216684 in Combination With Activated Charcoal | Participants received a single oral dose of 18 mg (milligram) LY2216684 and a single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal 1 hour after administration of LY2216684. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14 | 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 |
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| Activated Charcoal | Drug | Administered orally |
|
| United States |
| NOT COMPLETED |
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| years |
|
| 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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| OG001 | LY2216684 Alone | Participants received a single oral dose of 18 mg LY2216684. |
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|
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| Primary | Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 | The Cmax of LY2216684 was assessed. The Cmax was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric LSMeans were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax. | All participants who were randomized, for whom Cmax data were available, and who were not excluded due to vomiting within twice the median time to maximum plasma concentration (tmax) of LY2216684. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | nanogram/milliliter (ng/mL) | Predose, up to 72 hours after administration of study drug |
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|
|
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| Primary | Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684 | The tmax for LY2216684 was assessed. | All participants who were randomized, for whom tmax data were available, and who were not excluded due to vomiting within twice the median tmax of LY2216684. | Posted | Median | Full Range | hours | Predose, up to 72 hours after administration of study drug |
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| 0 |
| 22 |
| 9 |
| 22 |
| EG001 | LY2216684 Alone | Participants received a single oral dose of 18 mg LY2216684. | 0 | 20 | 7 | 20 |
| Vomiting | Gastrointestinal disorders | MedDRA 14 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 14 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14 | Systematic Assessment |
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| Urinary hesitation | Renal and urinary disorders | MedDRA 14 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14 | Systematic Assessment |
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