Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2886721 · 5 trials · 3 indications
AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721.
Cmax following administration of a single dose of 70 or 280 mg LY2886721.
AUC0-∞ following administration of a single dose of 70 mg LY2886721.
Cmax following administration of a single dose of 70 mg LY2886721.
Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir).
Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo.
Data presented are the number of participants who experienced treatment-emergent adverse events. A summary of serious adverse events and other non-serious adverse events, regardless of causality is reported in the Adverse Events module.
Urinary and fecal excretion of LY2886721 radioactivity over time was expressed as a percentage of the total radioactive dose administered. The amount of drug-related material excreted in urine and feces (Ae) at a specific collection interval (i) was calculated as the product of radioactivity concentration and volume or weight. The Ae values for each collection interval were then summed and calculated as Total Ae=Ae(i1)+Ae(i2)+Ae(in). The percentage of the total radiolabeled dose administered that was excreted in feces or urine=\[(Total Ae)/(Total radioactive dose administered)\]\*100.
A summary of serious adverse events and other nonserious adverse events located in Reported Adverse Event section. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in other LY2886721 groups received LY2886721 in fasted state. Due to crossover design in Part 1, results reported by treatment; thus, participants are included in multiple arms.
| Arm | Type | Description |
|---|---|---|
| Cohort A: 70 mg LY2886721 | EXPERIMENTAL | Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721. |
| Cohort A: Placebo | PLACEBO_COMPARATOR | Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule). |
| Cohort B: 70 mg LY2886721 | EXPERIMENTAL | Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721. |
| Cohort B: Placebo | PLACEBO_COMPARATOR | Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule). |
| Cohort C: 280 mg LY2886721 | EXPERIMENTAL | Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721. |
| Cohort C: Placebo | PLACEBO_COMPARATOR | Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules). |
| Placebo | PLACEBO_COMPARATOR | Single oral dose and/or once daily (QD) oral dosing for 14 consecutive days |
| 35 mg LY2886721 | EXPERIMENTAL | QD oral dosing for 14 consecutive days |
| 70 mg LY2886721 | EXPERIMENTAL | Single oral dose or single oral dose followed by QD oral dosing for 14 consecutive days |
| 140 mg LY2886721 | EXPERIMENTAL | Single oral dose |
| Radiolabeled LY2886721 | EXPERIMENTAL | Single 25 milligram (mg) oral dose containing 80 microCuries of radiolabeled LY2886721 |
| LY2886721 | EXPERIMENTAL | - |
| LY2886721 Part 1: Cohort A/B | EXPERIMENTAL | Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods |
| Placebo Part 1: Cohort A/B | PLACEBO_COMPARATOR | Single dose in up to 1 period |
| LY2886721 Part 2: Cohort C | EXPERIMENTAL | Single 10 mg dose of LY2886721, dose determined by Part 1 |
| LY2886721 Part 2: Cohort D | EXPERIMENTAL | Single 35 mg dose of LY2886721, dose determined by Part 1 |
| Placebo Part 2: Cohort C/D | PLACEBO_COMPARATOR | Single dose |
| Name | Type | Description |
|---|---|---|
| LY2886721 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square meter (kg/m\^2), inclusive, at screening. There are no restrictions on BMI in participants diagnosed with Alzheimer's disease. * Healthy participants should not be taking any concomitant medicat...
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LY2886721 is an investigational small molecule being studied for Alzheimer's disease. It has been evaluated in Phase 1 clinical trials in healthy volunteers and in participants with Alzheimer's disease. The drug is not approved and remains in clinical development.
LY2886721 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company has sponsored Phase 1 clinical trials of the drug in the United States.
LY2886721 is in Phase 1 clinical development. All completed trials of the drug are Phase 1 studies. The drug is investigational and has not been approved by regulatory authorities.
LY2886721 has been studied in several completed Phase 1 trials, including NCT01133405, NCT01227252, NCT01367262, and NCT01534273. These trials evaluated single doses, multiple doses, and the disposition of a carbon-14-labeled form of the drug in healthy participants.
LY2886721 and [14C]-LY2886721 are related forms of the same drug. The carbon-14-labeled version was used in a specific study, NCT01367262, to track the drug's disposition after oral administration in healthy male participants.