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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPCC | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s). The effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information about any side effects that may occur will also be collected.
This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B will last about 60 days including follow-up. Screening may occur up to 28 days before the first dose of study drug. Participants are only allowed to enroll in one part.
This study is for research purposes only and is not intended to treat any medical condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib Part A | Experimental | Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods. |
|
| Abemaciclib Part B | Experimental | R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods. |
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| Abemaciclib Part C | Experimental | T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib Capsules (Reference Formulation) | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) | Area under the concentration versus time curve from zero to infinity. | Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose |
| PK: Maximum Observed Drug Concentration (Cmax) | Maximum observed drug concentration. | Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 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 |
|---|---|---|---|---|---|---|
| Daytona Beach Clinical Research Unit | Daytona Beach | Florida | 32117 | United States | ||
| Evansville Clinical Research Unit |
A 2- and 3-period crossover study conducted in 3 parts, with Part A followed by Parts B and C. Participants received single oral doses of abemaciclib on 2 separate occasions in Parts A and C and on 3 separate occasions in Part B.There was a washout interval of at least 16 days between periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Abemaciclib (R,T150 ) | Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods. |
| FG001 | Part A: Abemaciclib (T150,R) | T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules administered orally on Day 1 in each of 2 periods. |
| FG002 | Part B: Abemaciclib (R,T150,T50 ) | R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods. |
| FG003 | Part B: Abemaciclib (T150,T50,R) | T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods. |
| FG004 | Part B: Abemaciclib (T50,R,T150) | T50 = 3 x 50 mg abemaciclib tablets, R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet administered orally on Day 1 in each of 3 periods. |
| FG005 | Part B: Abemaciclib (R,T50,T150) | R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets, T150 = 150 mg abemaciclib tablet administered orally on Day 1 in each of 3 periods. |
| FG006 | Part B: Abemaciclib (T150,R,T50) | T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods. |
| FG007 | Part B: Abemaciclib (T50,T150,R) | T50 = 3 x 50 mg abemaciclib tablets, T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules administered orally on Day 1 in each of 3 periods. |
| FG008 | Part C: Abemaciclib (T150 Fed, T150 Fasted) | T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally. |
| FG009 | Part C: Abemaciclib (T150 Fasted, T150 Fed) | T150 Fasted and T150 Fed = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout 1 |
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| Period 2 |
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| Washout 2 |
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| Period 3 |
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All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Abemaciclib | Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods. |
| BG001 | Part B Abemaciclib |
| 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 (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) | Area under the concentration versus time curve from zero to infinity. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour/milliliter (ng*hr/mL) | Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose |
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All randomized participants who received at least one dose 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 | Part A: 3 x 50 mg (R) | 3 x 50 milligrams (mg) abemaciclib capsules (reference formulation [R]) administered orally on Day 1 of 1 period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | 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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| Abemaciclib Tablet (Test Formulation) | Drug | Administered orally |
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| Evansville |
| Indiana |
| 47710 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
| BG002 | Part C Abemaciclib | T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally. |
| BG003 | Total | Total of all reporting groups |
| 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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3 x 50 mg abemaciclib capsules (reference formulation[R]) administered orally on Day 1 of 1 period. |
| OG002 | Part B: 150 mg Abemaciclib (T150) | 150 mg abemaciclib tablet (test formulation[T150]) administered orally on Day 1 of 1 period. |
| OG003 | Part B: 3 x 50 mg Abemaciclib (T50) | 3 x 50 mg abemaciclib tablets (T50) administered orally on Day 1 of 1 period. |
| OG004 | Part B: 3 x 50 mg Abemaciclib (R) | 3 x 50 mg abemaciclib capsules (reference formulation[R]) administered orally on Day 1 of 1 period. |
| OG005 | Part C: 150 mg Abemaciclib (Fed) | 150 mg abemaciclib tablet (test formulation [T150]) with a meal administered orally on Day 1 of 1 period. |
| OG006 | Part C: 150 mg Abemaciclib (Fasted) | 150 mg abemaciclib tablet (test formulation[T150]) without a meal administered orally on Day 1 of 1 period. |
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| Primary | PK: Maximum Observed Drug Concentration (Cmax) | Maximum observed drug concentration. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose |
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|
|
| 0 |
| 14 |
| 7 |
| 14 |
| EG001 | Part A: 1 x 150 mg (T150) | 150 mg abemaciclib tablet (test formulation[T150]) administered orally on Day 1 of 1 period. | 0 | 14 | 6 | 14 |
| EG002 | Part B: 3 x 50 mg (R) | 3 x 50 milligrams (mg) abemaciclib capsules (reference formulation[R]) administered orally on Day 1 of 1 period. | 0 | 88 | 21 | 88 |
| EG003 | Part B 1 x 150 mg (T150) | 150 mg abemaciclib tablet (test formulation[T150]) administered orally on Day 1 of 1 period. | 0 | 87 | 17 | 87 |
| EG004 | Part B 3 x 50 mg (T50) | 3 x 50 mg abemaciclib tablets (test formulation[T50]) administered orally on Day 1 of 1 period. | 0 | 88 | 22 | 88 |
| EG005 | Part C: (T150 Fed, T150 Fasted) | 150 mg abemaciclib tablet (test formulation [T150]) with a meal and then without a meal administered orally on Day 1 of 1 period.. | 0 | 24 | 3 | 24 |
| EG006 | Part C: (T150 Fasted, T150 Fed) | 150 mg abemaciclib tablet (test formulation [T150]) without a meal and then with a meal administered orally on Day 1 of 1 period. | 0 | 24 | 1 | 24 |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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