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| ID | Type | Description | Link |
|---|---|---|---|
| I4O-MC-BACB | Other Identifier | Eli Lilly and Company |
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This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2886721 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2886721 | Drug | 5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Effects | Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure. | Predose up to Day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721 | Predose (Day 14) up to Day 19 | |
| Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721 | Area under the concentration versus time curve during 1 dosing interval (1 dosing interval=24 hours) at steady state (AUCτ,ss) is being reported for this outcome measure. |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Glendale | California | 91206 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo was administered orally as capsules, once daily for 14 days. |
| FG001 | 5 mg LY2886721 | A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days. |
| FG002 | 15 mg LY2886721 | A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. |
| FG003 | 35 mg LY2886721 | A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo was administered orally as capsules, once daily for 14 days. |
| BG001 | 5 mg LY2886721 | A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Clinically Significant Effects | Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure. | All randomized participants were included in the analysis. | Posted | Count of Participants | Participants | No | Predose up to Day 70 |
|
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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 | Placebo was administered orally as capsules, once daily for 14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingivitis | Gastrointestinal disorders | MedDRA 13.0 | 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 |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000596181 | N-(3-(2-amino-4a,5,7,7a-tetrahydro-4H-furo(3,4-d)(1,3)thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide |
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| Placebo | Drug | Administered orally as capsules, daily for 14 days |
|
| Predose (Day 14) to 24 Hours post-dose (Day 15) |
| Plasma Amyloid Beta (Aβ) 1-40 Concentration | The minimum concentration (Cnadir) is being reported for this outcome measure. | Predose (Day 14) up to Day 19 |
| Cerebrospinal Fluid (CSF) Concentration of LY2886721 | 24 Hours post-dose (Day 15) |
| Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration | The Least Squares means were adjusted for baseline concentration. | Predose (Day 14), 24 Hours post-dose (Day 15) |
| United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | 15 mg LY2886721 | A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. |
| BG003 | 35 mg LY2886721 | A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 15 mg LY2886721 | A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. |
| OG003 | 35 mg LY2886721 | A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. |
|
|
| Secondary | Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721 | All participants who received study drug on Day 14 and had evaluable pharmacokinetic data were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose (Day 14) up to Day 19 |
|
|
|
| Secondary | Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721 | Area under the concentration versus time curve during 1 dosing interval (1 dosing interval=24 hours) at steady state (AUCτ,ss) is being reported for this outcome measure. | All participants who received study drug on Day 14 and had evaluable pharmacokinetic data were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Predose (Day 14) to 24 Hours post-dose (Day 15) |
|
|
|
| Secondary | Plasma Amyloid Beta (Aβ) 1-40 Concentration | The minimum concentration (Cnadir) is being reported for this outcome measure. | All participants who received study drug on Day 14 and had evaluable pharmacodynamic data were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram per milliliter (pg/mL) | Predose (Day 14) up to Day 19 |
|
|
|
| Secondary | Cerebrospinal Fluid (CSF) Concentration of LY2886721 | A subset of all participants who received study drug on Day 14 and had evaluable pharmacodynamic data was included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 24 Hours post-dose (Day 15) |
|
|
|
| Secondary | Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration | The Least Squares means were adjusted for baseline concentration. | All participants who received study drug on Day 14 and had evaluable pharmacodynamic data were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | percent change (%) | Predose (Day 14), 24 Hours post-dose (Day 15) |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | 5 mg LY2886721 | A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days. | 0 | 10 | 2 | 10 |
| EG002 | 15 mg LY2886721 | A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. | 0 | 10 | 3 | 10 |
| EG003 | 35 mg LY2886721 | A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. | 0 | 10 | 3 | 10 |
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Visual field tests abnormal | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Libido decreased | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |