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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPBV | Other Identifier | Eli Lilly and Company |
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The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated.
This study will last approximately 3 weeks for each participant, including check-in and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib: Normal Hepatic Function | Experimental | Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function. |
|
| Abemaciclib: Mild Hepatic Impairment | Experimental | Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment. |
|
| Abemaciclib: Moderate Hepatic Impairment | Experimental | Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment. |
|
| Abemaciclib: Severe Hepatic Impairment | Experimental | Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered Orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites | Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose | |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites | Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose |
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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 |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Lakewood | Colorado | 80228 | United States | ||
| Clinical Pharmacology of Miami (CPMI) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abemaciclib: Normal Hepatic Function | 200 milligrams (mg) abemaciclib administered once, orally, to participants with normal hepatic function. |
| FG001 | Abemaciclib: Mild Hepatic Impairment | 200 mg abemaciclib administered once, orally, to participants with mild hepatic impairment. |
| FG002 | Abemaciclib: Moderate Hepatic Impairment | 200 mg abemaciclib administered once, orally, to participants with moderate hepatic impairment. |
| FG003 | Abemaciclib: Severe Hepatic Impairment | 200 mg abemaciclib administered once, orally, to participants with severe hepatic impairment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received abemaciclib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Abemaciclib: Normal Hepatic Function | 200 mg abemaciclib administered once, orally, to participants with normal hepatic function. |
| BG001 | Abemaciclib: Mild Hepatic Impairment |
| Units | Counts |
|---|---|
| Participants |
|
| 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 (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites | All participants who received abemaciclib and had evaluable plasma values. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose |
|
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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 | Abemaciclib: Normal Hepatic Function | 200 mg abemaciclib administered once, orally, to participants with normal hepatic function. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 | 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 |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000590451 | abemaciclib |
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|
| Miami |
| Florida |
| 33014 |
| United States |
| Orlando Clinical Research Center (OCRC) | Orlando | Florida | 32809 | United States |
| Indiana University - Digestive and Liver Diseases | Indianapolis | Indiana | 46202 | United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
200 mg abemaciclib administered once, orally, to participants with mild hepatic impairment.
| BG002 | Abemaciclib: Moderate Hepatic Impairment | 200 mg abemaciclib administered once, orally, to participants with moderate hepatic impairment. |
| BG003 | Abemaciclib: Severe Hepatic Impairment | 200 mg abemaciclib administered once, orally, to participants with severe hepatic impairment. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Abemaciclib: Moderate Hepatic Impairment | 200 mg abemaciclib administered once, orally, to participants with moderate hepatic impairment. |
| OG003 | Abemaciclib: Severe Hepatic Impairment | 200 mg abemaciclib administered once, orally, to participants with severe hepatic impairment. |
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites | All participants who received abemaciclib and had evaluable plasma values. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliliter (ng*h/mL) | Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose |
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Abemaciclib: Mild Hepatic Impairment | 200 mg abemaciclib administered once, orally, to participants with mild hepatic impairment. | 0 | 9 | 6 | 9 |
| EG002 | Abemaciclib: Moderate Hepatic Impairment | 200 mg abemaciclib administered once, orally, to participants with moderate hepatic impairment. | 1 | 10 | 7 | 10 |
| EG003 | Abemaciclib: Severe Hepatic Impairment | 200 mg abemaciclib administered once, orally, to participants with severe hepatic impairment. | 0 | 6 | 3 | 6 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| LSN2839567 |
|
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| LSN3106729 |
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| LSN3106726 |
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