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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPCK | Other Identifier | Eli Lilly and Company |
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This study will look at how a single dose of abemaciclib will impact the body's ability to get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the effect of a single dose of abemaciclib on kidney function by measuring blood and urine markers. Side effects will also be documented.
Each participant will complete four study periods. During each study period, participants will stay in the clinical research unit for nine days and eight nights.
The study will last approximately 10 weeks, not including screening. Screening is required within 28 days prior to the start of the study.
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 |
|---|---|---|---|
| Placebo + Metformin | Placebo Comparator | Single dose of placebo administered orally followed by a single dose of metformin administered orally in one of four study periods. |
|
| Abemaciclib + Metformin | Experimental | Single dose of abemaciclib administered orally followed by a single dose of metformin administered orally in one of four study periods. |
|
| Placebo + Iohexol | Placebo Comparator | Single dose of placebo administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods. |
|
| Abemaciclib + Iohexol | Experimental | Single dose of abemaciclib administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Metformin | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of Metformin was evaluated. | Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin was evaluated. | Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose |
| Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin | Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin was evaluated. | Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol | Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol was evaluated. | Pre infusion, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 hours post infusion |
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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 |
|---|---|---|---|---|---|---|
| Dallas Clinical Research Unit | Dallas | Texas | 75247 | United States |
Follow-up visit of 16 to 20 days occurred after administration of the last dose of study drug.
Participants were randomized to one of the four sequences and received either placebo or Abemaciclib along with Metformin or Iohexol. A washout period of at least 16 days following Abemaciclib administration & at least 5 days following placebo administration occurred between each period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Single oral dose of 400 milligram (mg) Abemaciclib or Placebo was administered along with single oral dose of 1000 mg Metformin or 5 milliliter (3235 mg) Iohexol by Intravenous (IV) infusion on day 1 of each period as per the dosing schedule (Period 1 : Placebo + Metformin;Period 2: Abemaciclib + Metformin;Period 3: Placebo + Iohexol;Period 4: Abemaciclib + Iohexol). |
| FG001 | Sequence 2 | Single oral dose of 400 (mg) Abemaciclib or Placebo was administered along with single oral dose of 1000 mg Metformin or 5 mL (3235 mg) Iohexol by Intravenous (IV) infusion on day 1 of each period as per the dosing schedule (Period 1: Abemaciclib + Metformin;Period 2: Placebo + Metformin;Period 3: Abemaciclib + Iohexol;Period 4: Placebo + Iohexol). |
| FG002 | Sequence 3 | Single oral dose of 400 (mg) Abemaciclib or Placebo was administered along with single oral dose of 1000 mg Metformin or 5 mL (3235 mg) Iohexol by Intravenous (IV) infusion on day 1 of each period as per the dosing schedule (Period 1: Placebo + Iohexol;Period 2: Abemaciclib + Iohexol;Period 3: Placebo + Metformin;Period 4: Abemaciclib + Metformin). |
| FG003 | Sequence 4 | Single oral dose of 400 milligram (mg) Abemaciclib or Placebo was administered along with single oral dose of 1000 mg Metformin or 5 mL (3235 mg) Iohexol by Intravenous (IV) infusion on day 1 of each period as per the dosing schedule (Period 1: Abemaciclib + Iohexol;Period 2: Placebo + Iohexol;Period 3: Abemaciclib + Metformin;Period 4: Placebo + Metformin). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period 1 |
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| Period 2 |
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| Washout Period 2 |
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| Period 3 |
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| Washout Period 3 |
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| Period 4 |
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| Follow-up Visit |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Single oral dose of placebo or 400 mg Abemaciclib is administered along with 1000 mg Metformin orally or 5 mL (3235 mg) Iohexol by IV infusion on day 1 as per the dosing schedule in each period. |
| 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 Time Zero to Infinity (AUC[0-∞]) of Metformin | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of Metformin was evaluated. | All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*Hour per Milliliter (ng*h/mL) | Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose |
|
Up to 92 days
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 | Placebo + 1000 mg Metformin | Single dose of placebo administered orally followed by a single oral dose of 1000 mg Metformin on day 1 of each period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 19.0 | 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 |
|---|---|
| C000590451 | abemaciclib |
| D008687 | Metformin |
| D007472 | Iohexol |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014283 |
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| Metformin | Drug | Administered orally |
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| Iohexol | Drug | Administered intravenously (IV) |
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| Placebo | Drug | Administered orally |
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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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| 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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| 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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| Body Mass Index (BMI) | Mean | Standard Deviation | Kilogram per square meter (kg/m^2) |
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| 400 mg Abemaciclib + 1000 mg Metformin |
Single dose of 400 mg Abemaciclib administered orally followed by a single oral dose of 1000 mg Metformin on day 1 of each period. |
|
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| Primary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin was evaluated. | All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose |
|
|
|
| Primary | Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin | Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin was evaluated. | All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per Hour (L/h) | Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose |
|
|
|
| Secondary | Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol | Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol was evaluated. | All randomized participants who received at least one dose of study Abemaciclib or placebo along with Iohexol & had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliter per minute (mL/min) | Pre infusion, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 hours post infusion |
|
|
|
| 0 |
| 33 |
| 8 |
| 33 |
| EG001 | 400 mg Abemaciclib + 1000 mg Metformin | Single dose of 400 mg Abemaciclib administered orally followed by a single oral dose of 1000 mg Metformin on day 1 of each period. | 0 | 35 | 11 | 35 |
| EG002 | Placebo + 5 mL Iohexol | Single dose of placebo administered orally followed by a single dose 5 mL (3235 mg) Iohexol administered intravenously (IV) on day 1 of each period. | 0 | 32 | 0 | 32 |
| EG003 | 400 mg Abemaciclib + 5 mL Iohexol | Single dose of 400 mg Abemaciclib administered orally followed by a single dose 5 mL (3235 mg) Iohexol administered intravenously (IV) on day 1 of each period. | 0 | 33 | 6 | 33 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |