Approval Probability
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Adjusted LOA
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Also known as LY3314814, AZD3293
Lanabecestat · 7 trials · 4 indications
Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
| Arm | Type | Description |
|---|---|---|
| Rosuvastatin | EXPERIMENTAL | Period 1: 20 mg rosuvastatin administered once orally (PO) |
| Lanabecestat + Rosuvastatin | EXPERIMENTAL | Period 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8 |
| Lanabecestat Reference Fasted | EXPERIMENTAL | Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. |
| Lanabecestat Test Fasted | EXPERIMENTAL | Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. |
| Lanabecestat Test Non Fasted | EXPERIMENTAL | Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. |
| 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. |
| Warfarin | EXPERIMENTAL | Single oral dose of 15 mg warfarin on Day 1. |
| Lanabecestat + Warfarin | EXPERIMENTAL | Lanabecestat administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22. |
| Cohort A | EXPERIMENTAL | 500 microgram (mcg) midazolam, single oral dose on Days 1, 17, and 35; 20 mg simvastatin, single oral dose on Days 2 and 36; 250 microgram (mcg) midazolam, intravenous (IV) on Days 3 and 37; 50 mg lanabecestat, single oral dose on Day 4; 50 mg lanabecestat, single oral dose, Days 10 to 37 |
| Cohort B | EXPERIMENTAL | 5 mg donepezil, single oral dose on Day 1, Period 1; 50 mg lanabecestat, single oral dose Days 1 to 43, Period 2; 5 mg donepezil, single oral dose on Day 28, Period 2 |
| AZD3293 dose A | EXPERIMENTAL | AZD3293 therapeutic dose oral solution (low dose) |
| AZD3293 dose B | EXPERIMENTAL | AZD3293 supratherapeutic dose oral solution (high dose) |
| Placebo | PLACEBO_COMPARATOR | Placebo oral solution |
| Moxifloxacin | ACTIVE_COMPARATOR | Moxifloxacin tablet |
| AZD3293 | EXPERIMENTAL | Part 1: Up to 6 sequential cohorts of healthy elderly subjects are planned, with multiple ascending doses, starting with 5 mg (subject to confirmation by the Safety Review Committee) Part 2: Up to 16 mild-to-moderate AD patients administered one to up to 3 dosage levels of AZD3293 |
| Name | Type | Description |
|---|---|---|
| Lanabecestat | DRUG | Administered orally |
| Rosuvastatin | DRUG | Administered orally |
| Dabigatran etexilate | DRUG | Administered orally |
| Warfarin | DRUG | Administered orally |
| Simvastatin | DRUG | 20 mg simvastatin will be administered orally as 1 × 20-mg tablet |
| Midazolam | DRUG | 500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup |
| Donepezil | DRUG | 5 mg donepezil will be administered orally as 1 × 5-mg tablet |
| AZD3293 | DRUG | AZD3293 oral solution - one single dose (low dose). |
| Placebo | DRUG | Placebo oral solution - one single dose |
| Moxifloxacin | DRUG | Moxifloxacin tablet - one single dose |
Inclusion Criteria: * Women not of childbearing potential may participate and include those who are: * Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or * Postmenopausal - defined as women over 5...
Lanabecestat is an investigational small molecule drug developed by AstraZeneca PLC (ticker AZN). It is a BACE1 inhibitor that has been studied in Phase 1 clinical trials, primarily in healthy volunteers. The specific medical conditions it is intended to treat have not been disclosed.
Lanabecestat targets BACE1, also known as beta-secretase 1. It is classified as a BACE1 inhibitor. By inhibiting this enzyme, the drug is designed to interfere with the biological pathway in which BACE1 plays a role. The clinical program has focused on Phase 1 studies in healthy participants.
Lanabecestat is developed by AstraZeneca PLC, which trades under the ticker AZN. The drug, also identified in study records as LY3314814, has been evaluated in a series of Phase 1 clinical trials sponsored by the company.
Lanabecestat is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Five Phase 1 trials have been completed, all of which are now closed to enrollment, and no active trials are currently listed.
Lanabecestat has been studied in five completed Phase 1 trials, including NCT03019549, which examined the drug with rosuvastatin in 42 healthy participants; NCT02663128, a study in 18 healthy participants; NCT02568397, a drug-drug interaction study in 60 healthy participants; and NCT02540668, which evaluated the drug with warfarin in 15 healthy participants. Total enrollment across the program was 217.
Yes, Lanabecestat is also known as LY3314814. The two names refer to the same investigational BACE1 inhibitor developed by AstraZeneca PLC. Clinical trial records for the drug use both the name Lanabecestat and the code LY3314814 interchangeably.