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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPBG | Other Identifier | Eli Lilly and Company |
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Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2835219 Standard | Experimental | Single oral dose of LY2835219 given with a standard meal in one of three study periods. |
|
| LY2835219 Fasted | Experimental | Single oral dose of LY2835219 given with no food in one of three periods. |
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| LY2835219 High-Fat | Experimental | Single oral dose of LY2835219 given with a high fat meal in one of three periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2835219 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period | |
| Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period | |
| Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period | |
| Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
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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. | Dallas | Texas | 75247 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, Fasted State, High-Fat Meal. Dosing occasions were separated by at least 14 days. |
| FG001 | Sequence 2 | Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, High-Fat Meal, Fasted State. Dosing occasions were separated by at least 14 days. |
| FG002 | Sequence 3 | Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Fasted State, High-Fat Meal, Standard Meal. Dosing occasions were separated by at least 14 days. |
| FG003 | Sequence 4 | Single oral dose of 200 mg LY2835219 on 3 Occasions: Fasted State, Standard Meal, High-Fat Meal. Dosing occasions were separated by at least 14 days. |
| FG004 | Sequence 5 | Single oral dose of 200 mg LY2835219 on 3 Occasions: High-Fat Meal, Fasted State, Standard Meal. Dosing occasions were separated by at least 14 days. |
| FG005 | Sequence 6 | Single Oral Dose of 200 mg LY2835219 on 3 Occasions: High-Fat Meal, Standard Meal, Fasted State. Dosing occasions were separated by at least 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment 1 |
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| Treatment 2 |
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| Treatment 3 |
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Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, Fasted State, High-Fat Meal.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, Fasted State, High-Fat Meal. Dosing occasions were separated by at least 14 days. |
| 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: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms | All randomized participants receiving at least one dose of the investigational product. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
|
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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 | LY2835219 Standard | Single oral dose of LY2835219 given with a standard meal in one of three study periods. LY2835219: Administered orally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | 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 |
|---|---|
| C000590451 | abemaciclib |
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| Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
| Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20) | Area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LSN3106726 (M20), an active metabolite of LY2835219. | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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|
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| Primary | Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms | All randomized participants receiving at least one dose of the investigational product. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/mL (ng*h/mL) | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
|
|
|
|
| Primary | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms | All randomized participants receiving at least one dose of the investigational product. | Posted | Median | Full Range | hour (h) | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
|
|
|
|
| Secondary | Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm | All randomized participants receiving at least one dose of the investigational product. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
|
|
|
| Secondary | Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm | All randomized participants receiving at least one dose of the investigational product. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
|
|
|
| Secondary | Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm | All randomized participants receiving at least one dose of the investigational product. | Posted | Median | Full Range | hour (h) | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
|
|
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| Secondary | Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20) | Area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LSN3106726 (M20), an active metabolite of LY2835219. | All randomized participants receiving at least one dose of the investigational product. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |
|
|
|
| 0 |
| 23 |
| 4 |
| 23 |
| EG001 | LY2835219 Fasted | Single oral dose of LY2835219 given with no food in one of three periods. LY2835219: Administered orally. | 0 | 23 | 6 | 23 |
| EG002 | LY2835219 High-Fat | Single oral dose of LY2835219 given with a high fat meal in one of three periods. LY2835219: Administered orally. | 0 | 24 | 4 | 24 |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
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