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Also known as AZD3293 oral solution, beta secretase inhibitor, Lanabecestat, LY3314814
AZD3293 · 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...
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AZD3293 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for Alzheimer's Disease, including mild-to-moderate Alzheimer's Disease patients. It is in Phase 1 clinical development and has been studied in placebo-controlled, randomized, double-blind trials. It is not described as approved, so it remains an investigational agent in clinical development.
AZD3293 is being studied for Alzheimer's Disease, including mild-to-moderate Alzheimer's Disease patients. The clinical work to date has been Phase 1, including a thorough QT study in healthy male volunteers and a multiple dose study in healthy elderly volunteers and Alzheimer's patients. It is investigational and not described as approved for any use.
AZD3293 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor associated with the Phase 1 clinical program for AZD3293 in Alzheimer's Disease and mild-to-moderate Alzheimer's Disease patients.
AZD3293 is in Phase 1 clinical development. Its trials are Phase 1 studies, and the program includes one completed trial with 52 participants and another completed Phase 1 study with 47 participants. AZD3293 is investigational and is not described as FDA approved.
AZD3293 has been studied in two completed Phase 1 trials. NCT02040987 was a thorough QT study in healthy male volunteers with 52 participants in the United States. NCT01795339 was a two-part multiple dose study assessing safety and effects in healthy elderly volunteers and mild-to-moderate Alzheimer's patients, with 47 participants.
Yes. AZD3293 is also known as AZD3293 oral solution. Both names refer to the same investigational small molecule developed by AstraZeneca PLC for Alzheimer's Disease, including mild-to-moderate Alzheimer's Disease patients, and studied in Phase 1 clinical trials.