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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPBE | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to assess how the body handles Abemaciclib when it is given with another drug called clarithromycin. The study doctor will measure the amount of Abemaciclib that is absorbed into the blood stream and the time that it takes to remove Abemaciclib from the body. The safety and tolerability of these drugs will be studied.
Each participant will complete 2 study periods in fixed order. After screening, Period 1 will last approximately 8 days and Period 2 will last approximately 15 days. Participants who complete Period 2 may continue to receive Abemaciclib in 28-day cycles until discontinuation criteria are met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib Alone Period 1 | Experimental | 50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1. |
|
| Abemaciclib + Clarithromycin Period 2 | Experimental | Clarithromycin 500 milligram (mg) orally twice daily for 12 days. Single oral dose of Abemaciclib 50 mg on Period 2 Day 5. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib. |
|
| Abemaciclib Safety Extension | Experimental | After completing Period 2, eligible participants continued to receive 200 mg Abemaciclib every 12 hours (Q12H) on a 28-day cycle in a safety-extension phase until discontinuation criteria were met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib | Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose | |
| PK: Maximum Concentration (Cmax) of Abemaciclib | Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96,120,144,168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose |
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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 |
|---|---|---|---|---|---|---|
| Accelerated Comm. Oncology Research Network (ACORN) | Memphis | Tennessee | 38119 | United States | ||
| The West Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24919854 | Derived | Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abemaciclib Alone Then Abemaciclib + Clarithromycin | 50 mg single oral dose of Abemaciclib was administered on Period 1 Day 1 and on Period 2 Day 5. Clarithromycin 500 milligram (mg) orally twice daily for 12 days. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib. After completing Period 2, eligible participants continued to receive 200 mg Abemaciclib every 12 hours (Q12H) on a 28-day cycle in a safety-extension phase until discontinuation criteria were met. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abemaciclib Alone Period 1 |
|
| ||||||||||||||||||||||||
| Abemaciclib + Clarithromycin Period 2 |
| |||||||||||||||||||||||||
| Abemaciclib Safety-Extension Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abemaciclib Then Abemaciclib + Clarithromycin | 50 mg single oral dose of Abemaciclib was administered on Period 1 Day 1 and on Period 2 Day 5. Clarithromycin 500 mg orally twice daily for 12 days. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib. After completing Period 2, eligible participants continued to receive 200 mg Abemaciclib Q12H on a 28-day cycle in a safety-extension phase until discontinuation criteria were met. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib | All participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter(mL) ng*h/mL | Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose |
|
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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 | 50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system 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 |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000590451 | abemaciclib |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Clarithromycin | Drug | Administered orally |
|
| Memphis |
| Tennessee |
| 38120 |
| United States |
| NOT COMPLETED |
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|
|
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram/square meter (kg/m2) |
|
| Eastern Cooperative Oncology Group (ECOG) Scale | ECOG 0 = Fully active, able to carry on all predisease performance without restriction ECOG 1 = Restricted in physically strenuous activity but ambulatory and able to carry out performance of a light or sedentary nature, for example, light housework, office work | Number | participants |
|
|
|
| Primary | PK: Maximum Concentration (Cmax) of Abemaciclib | All participants who received at least 1 dose of study drug and had evaluable cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96,120,144,168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose |
|
|
|
| 1 |
| 26 |
| 13 |
| 26 |
| EG001 | Clarithromycin | Clarithromycin 500 mg orally twice daily for 12 days | 1 | 24 | 7 | 24 |
| EG002 | Abemaciclib + Clarithromycin | Clarithromycin 500 mg orally twice daily for 12 days. Single oral dose of Abemaciclib on Period 2 Day 5 . Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib. | 1 | 21 | 10 | 21 |
| EG003 | Safety Extension Abemaciclib | After completing Period 2, eligible participants continued to receive 200 mg Abemaciclib Q12H on a 28-day cycle in a safety-extension phase until discontinuation criteria were met. | 15 | 20 | 19 | 20 |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Cystitis noninfective | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
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| Organic Chemicals |