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| ID | Type | Description | Link |
|---|---|---|---|
| I3J-MC-LACE |
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This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2811376 single doses, how the body handles the drug, and the drug's effect on the body.
This is a Phase 1 study with 2 parts, both in healthy subjects. Part 1 is a subject- and investigator-blind, placebo-controlled, randomized, 3 period, crossover study. Part 1 will assess the safety and tolerability of LY2811376 single doses, how the body handles the drug, and the drug's effect on the body. Part 2 is a subject- and investigator-blind, placebo-controlled, randomized study to assess the safety and tolerability of a LY2811376 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2811376 Part 1 | Experimental | LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods. |
|
| Placebo Part 1 | Placebo Comparator | once a day or twice a day for 1 day in up to 3 periods. |
|
| LY2811376 - Part 2 low dose | Experimental | Single dose of LY2811376, dose determined by part 1 |
|
| LY2811376 - Part 2 high dose | Experimental | Single dose of LY2811376, dose determined by part 1 |
|
| Placebo Part 2 | Placebo Comparator | single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2811376 | Drug | Oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Effects | Predose and up to Day 6 of each period |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of LY2811376 (Cmax) | Predose and up to Day 6 of each period | |
| Plasma concentration of LY2811376 (AUC) | Predose and up to Day 6 of each period | |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25404952 | Derived | Portelius E, Dean RA, Andreasson U, Mattsson N, Westerlund A, Olsson M, Demattos RB, Racke MM, Zetterberg H, May PC, Blennow K. beta-site amyloid precursor protein-cleaving enzyme 1(BACE1) inhibitor treatment induces Abeta5-X peptides through alternative amyloid precursor protein cleavage. Alzheimers Res Ther. 2014 Nov 17;6(5-8):75. doi: 10.1186/s13195-014-0075-0. eCollection 2014. |
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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 |
|---|---|
| C569204 | LY2811376 |
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| Placebo | Drug | Oral capsules |
|
| Amyloid beta 1-40 plasma concentrations |
| Predose and up to Day 6 of each period |
| Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only) | Predose and up to 36 hours |
| Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only) | Predose and up to 36 hours |
| Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only) | Predose and up to 36 hours |
| United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |