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| ID | Type | Description | Link |
|---|---|---|---|
| I2K-MC-ZZBQ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine the effect of activated charcoal and dosing time on the absorption of LY2624803 in healthy subjects. In this crossover study, there are three treatments with a washout period of at least 7 days in between treatments. Each subject will participate in all three treatments with random assignment to the treatment sequence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 mg LY2624803 Alone Morning Dosing | Experimental | Participants received 6 milligrams (mg) LY2624803 alone orally (po) at approximately 0800 hours following an overnight fast. |
|
| 6 mg LY2624803 Morning Dosing + Activated Charcoal | Experimental | Participants received 6 mg LY2624803 po at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola. |
|
| 6 mg LY2624803 Alone Evening Dosing | Experimental | Participants received 6 mg LY2624803 alone po at approximately 2200 hours following a 4-hour fast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2624803 | Drug | Administered orally (po), once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276 | AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276. | Predose and up to Day 4 |
| Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276, | Cmax estimated for both LY2624803 and the metabolite LSN2797276. | Predose and up to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276 | Tmax, estimated for both LY2624803 and the metabolite LSN2797276. | Predose and up to day 4 |
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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. | Leeds | West Yorkshire | LS2 9LH |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2624803 | Participants received each of the following 3 study treatments: LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast. LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola. LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2624803 | Participants received each of the following 3 study treatments: LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast. LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola. LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast. |
| 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 | Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276 | AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276. | All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Predose and up to Day 4 |
|
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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 | LY2624803 Morning Dosing | LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth 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 |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| Activated Charcoal | Other | Administered po |
|
| United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
| OG002 | LY2624803 Alone Evening Dosing | Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast. |
|
|
| Primary | Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276, | Cmax estimated for both LY2624803 and the metabolite LSN2797276. | All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose and up to Day 4 |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276 | Tmax, estimated for both LY2624803 and the metabolite LSN2797276. | All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data. | Posted | Median | Full Range | hours (h) | Predose and up to day 4 |
|
|
|
| 0 |
| 21 |
| 13 |
| 21 |
| EG001 | LY2624803 Morning Dosing + Activated Charcoal | LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola. | 0 | 21 | 8 | 21 |
| EG002 | LY2624803 Evening Dosing | LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast. | 0 | 21 | 10 | 21 |
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Abdominal pain upper | 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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| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | 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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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Neck 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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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Presyncope | 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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| Tremor | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal 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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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| D001523 |
| Mental Disorders |
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|