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| ID | Type | Description | Link |
|---|---|---|---|
| I8D-MC-AZEB | Other Identifier | Eli Lilly and Company. |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be measured. Information about any side effects that may occur will also be collected.
Participants will be on study for 21 days with a follow-up at least 7 days afterwards.
Screening will be undertaken within 45 days prior to enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental | Period 1: 20 mg rosuvastatin administered once orally (PO) |
|
| Lanabecestat + Rosuvastatin | Experimental | Period 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanabecestat | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin | Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin | 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814) | Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814) | Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose |
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Inclusion Criteria:
Women not of childbearing potential may participate and include those who are:
Caucasian and may be of Hispanic ethnicity
Body mass index (BMI) of 19 to 32 kilogram per meter square (kg/m²), inclusive, at the time of screening
Exclusion Criteria:
- Have a clinically significant abnormal blood pressure or heart rate (supine) as determined by the investigator
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
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| Label | URL |
|---|---|
| CSP | View source |
| SAP | View source |
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11 participants completed Period 1 but did not enter Period 2 because they did not meet the genotype criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | All participants received: Period 1, Day 1: single, PO dose 20 mg rosuvastatin with a seven day wash-out. Period 2: Day 1-7 single, PO dose 50 mg lanabecestat (LY3314814) with a single 20 mg rosuvastatin dose coadminstered on Day 8 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Washout |
| ||||||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All participants who received at least 1 dose of study drug. |
| 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): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin | Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin | All participants who received at least 1 dose of study drug, had evaluable PK parameters. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours times nanogram per milliliter | 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose |
|
Up to 5 months
All participants who received at least 1 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 | 20 mg Rosuvastatin | Period 1: rosuvastatin: 20 mg PO on Day 1 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical skin tear | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
11 participants completed Period 1 and then discontinued due to genotyping criteria.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Compnay | 800-545-5979 | Clinicaltrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2016 | Apr 25, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 21, 2016 | Apr 25, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C000608388 | lanabecestat |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Rosuvastatin | Drug | Administered orally |
|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat |
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat |
| .Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Genotype rsl045642 (ABCB1) | Results from genotype rsl045642 was used to explore polymorphisms in genes coding for certain transporters on the magnitude of the interaction between rosuvastatin and LY3314814. | Count of Participants | Participants |
|
20 mg rosuvastatin and 50 mg lanabescestat (LY3314814) administered in combination. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814) | Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814) | All participants who received at least 1 dose of study drug, had evaluable PK parameters. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours times nanograms per milliliter | Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat | All participants who received at least 1 dose of study drug and had evaluable PK data. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | .Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose |
|
|
|
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 50 mg Lanabecestat (LY3314814) | Period 2: Day 1-7,50 mg lanabecestat (LY3314814) PO once daily (QD) | 0 | 29 | 0 | 29 | 2 | 29 |
| EG002 | Lanabecestat (LY3314814) + 20 mg Rosuvastatin | Period 2: Lanabecestat (LY3314814) 50 mg PO Days 1-12 with a single dose of 20 mg rosuvastatin PO on Day 8 | 0 | 26 | 0 | 26 | 3 | 26 |
| Dizziness postural | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
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| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |