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| ID | Type | Description | Link |
|---|---|---|---|
| I8D-MC-AZEE | 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 learn about the effect of lanabecestat on how the body absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat when they are taken together. This study will last about 28 days and participants will be asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3 occasions. Screening is required within 30 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran Etexilate | Experimental | Single dose of dabigatran etexilate administered orally. |
|
| Lanabecestat and Dabigatran Etexilate | Experimental | Single dose of lanabecestat administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the lanabecestat dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanabecestat | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose | |
| Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose | |
| Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau) |
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Inclusion Criteria:
- Overtly healthy males and females
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 |
|---|---|---|---|---|---|---|
| Covance | Dallas | Texas | 75247 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran Etexilate | Single dose of dabigatran etexilate administered orally on Day 1. |
| FG001 | LY3314814 + Dabigatran Etexilate | Single dose of LY3314814 administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the LY3314814 dosing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Period 2 |
|
Received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Overall study population |
| 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 Concentration (Cmax) of Dabigatran | All participants who received at least one dose of study drug and have evaluable pharmacokinetic (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 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 | Dabigatran Etexilate | Single dose of 150mg dabigatran etexilate administered orally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingival pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5079 |
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| ID | Term |
|---|---|
| C000608388 | lanabecestat |
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Dabigatran etexilate | Drug | Administered orally |
|
| Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose |
| Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time | Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose |
| Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time | Ratio of maximum effect to baseline effect following administration of 150 mg dabigatran etexilate alone on Day 1, 50 mg LY3314814 and 150 mg dabigatran dosed concurrently on Day 16, and 50 mg LY3314814 and 150 mg dabigatran (dosed 4 hours later) on Day 20 | Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose |
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | LY3314814 and Dabigatran Etexilate Day 20 | Single dose of LY3314814 administered orally once daily on Days 3 to 21.Single dose of dabigatran etexilate administered orally 4 hours after LY3314814 administration on Day 20. |
|
|
| Primary | Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity) | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat | All participants who received one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau) | All participants who received one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose |
|
|
|
| Secondary | Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time | All participants who received at least one dose of study drug and had evaluable Pharmacodynamic (PD) data. | Posted | Mean | Standard Deviation | seconds*hour (s*h) | Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose |
|
|
|
| Secondary | Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time | Ratio of maximum effect to baseline effect following administration of 150 mg dabigatran etexilate alone on Day 1, 50 mg LY3314814 and 150 mg dabigatran dosed concurrently on Day 16, and 50 mg LY3314814 and 150 mg dabigatran (dosed 4 hours later) on Day 20 | All participants who received at least one dose of study drug and had evaluable Pharmacodynamic (PD) data. | Posted | Median | Full Range | ratio of maximum effect | Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose |
|
|
|
| 0 |
| 60 |
| 3 |
| 60 |
| EG001 | LY3314814 (AZD3293) | 50 mg LY3314814 administered orally alone on Day 15 | 0 | 60 | 8 | 60 |
| EG002 | LY3314814 and Dabigatran Etexilate Day 16 | Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on Day 16. | 0 | 58 | 2 | 58 |
| EG003 | LY3314814 and Dabigatran Etexilate Day 20 | Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on day 20. | 0 | 58 | 4 | 58 |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Vessel puncture site swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |