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| ID | Type | Description | Link |
|---|---|---|---|
| I8D-MC-AZEH | 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 measure how much of a new tablet formulation of lanabecestat gets into the blood stream and how long it takes the body to get rid of it, compared to the current tablet formulation of lanabecestat. The effect of a high fat meal on how quickly the body absorbs the new tablet formulation will also be evaluated. In addition any side effects of the study drug using both the new and current tablet formulations will be evaluated. The study will last about 22 days, with screening required within 30 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanabecestat Reference Fasted | Experimental | Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. |
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| Lanabecestat Test Fasted | Experimental | Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. |
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| Lanabecestat Test Non Fasted | Experimental | Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanabecestat | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293) | Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293) | Day 1 of Periods 1, 2, and 3:Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose | |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293) | Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose |
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Inclusion Criteria:
- Male participants: Will be sterile (including vasectomy) or agree to use an effective method of birth control and will not donate sperm during the study and for 3 months following the last dose of the investigational product
- Female participants: Women not of childbearing potential due to surgical sterilization or confirmed by medical history or menopause
- Are able to eat a high-fat, high-calorie meal within the defined time limit and abide by the food restrictions throughout the study
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 |
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Participants were randomized to 1 of 6 treatment sequences over 3 treatment periods that were 7 days long with a 7-day washout period between doses. Participants were either in a fasted state or fed state. Sequences contain a Reference (Fasted) dose; Test (Fasted) dose, and Test (Fed) dose: R (Fast)/ T (Fast)/ T (Fed), respectively.
To obtain representative age-related data, attempts were made to enroll at least 6 participants who were >55 years of age.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | LY3314814 (AZD3293): 50 milligram (mg) administered once orally (PO) in each of 3 treatment periods. Treatment sequence: Reference (R [Fasted])/ Test (T [Fasted])/ T (Fed) |
| FG001 | Sequence 2 | LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence: T (Fasted)/T (Fed)/ R (Fasted) |
| FG002 | Sequence 3 | LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T (Fed)/ R (Fasted)/ T (Fasted) |
| FG003 | Sequence 4 | LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T(Fed)/ T (Fasted)/ R (Fasted) |
| FG004 | Sequence 5 | LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence: R (Fasted)/T (Fed)/ T (Fasted) |
| FG005 | Sequence 6 | LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T (Fasted)/ R (Fasted)/ T (Fed) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
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| Period 1 |
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| Period 2 |
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Received at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | 18 to 55 Years | LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Reference formulation for fasted group Test formulation for fasted and non-fasted group |
| BG001 | > 55 Years |
| Units | Counts |
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| 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): Maximum Concentration (Cmax) of LY3314814 (AZD3293) | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose |
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Adverse events were analyzed and presented per respective formulation.
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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 | R (Fasted) | LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Reference formulation for fasted group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5079 |
| ID | Term |
|---|---|
| C000608388 | lanabecestat |
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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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LY3314814 (AZD3293): 50 mg administered once orally PO in each of 3 treatment periods. Reference formulation for fasted group Test formulation for fasted and non-fasted group
| BG002 | Total | Total of all reporting groups |
| years |
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| 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 |
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| OG002 | T (Fed) | LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for non-fasted group |
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| Primary | PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293) | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | Hour (h) | Day 1 of Periods 1, 2, and 3:Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose |
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|
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| Primary | PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293) | 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/milliliter (ng*h/mL) | Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose |
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|
|
| 0 |
| 18 |
| 5 |
| 18 |
| EG001 | T (Fasted) | LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for fasted group | 0 | 17 | 4 | 17 |
| EG002 | T (Fed) | LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for non-fasted group | 0 | 18 | 4 | 18 |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue 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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| Pain in extremity | 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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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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