Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lanabecestat · 5 trials · 1 indication
Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin
| 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 |
| 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 |
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 being developed by AstraZeneca PLC (AZN). It is currently in Phase 1 clinical development. The drug has been studied in healthy participants across multiple clinical trials, with a total enrollment of 217 individuals across five completed trials.
Lanabecestat is being studied for use in healthy participants. It is an investigational drug in Phase 1 clinical development, and its trials have focused on healthy volunteers to assess drug interactions and other pharmacological properties. It has not been approved for any medical condition.
Lanabecestat is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials of Lanabecestat in healthy participants to evaluate its safety and pharmacokinetics.
Lanabecestat is in Phase 1 clinical development. All five clinical trials of Lanabecestat have been completed, and none are currently active. The drug is investigational and has not been approved by regulatory authorities. Its trials have enrolled a total of 217 healthy participants.
Lanabecestat has been studied in five completed Phase 1 clinical trials, including NCT02406261, NCT02540668, NCT02568397, and NCT02663128. These trials enrolled healthy participants to evaluate drug-drug interactions and other pharmacological properties. All trials are completed, with no active studies ongoing.
Yes, Lanabecestat is also known as LY3314814. Clinical trial records for Lanabecestat, such as NCT02406261 and NCT02540668, refer to the drug as LY3314814. This alternative name is used in the titles of several Phase 1 studies conducted in healthy participants.