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Lanabecestat

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Nov 4, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials5
Total Enrollment217
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03019549A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With RosuvastatinPHASE1 COMPLETED 42 — — Jan 12, 2017May 22, 2017Nov 1, 20191 United States
NCT02663128A Study of Lanabecestat (LY3314814) in Healthy ParticipantsPHASE1 COMPLETED 18 — — Jan 31, 2016Mar 31, 2016Nov 1, 2019 - —
NCT02568397A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy ParticipantsPHASE1 COMPLETED 60 — — Oct 31, 2015Jan 31, 2016Nov 1, 20191 United States
NCT02540668A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy ParticipantsPHASE1 COMPLETED 15 — — Sep 30, 2015Jan 31, 2016Nov 4, 20191 United States
NCT02406261A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy ParticipantsPHASE1 COMPLETED 82 — — Apr 30, 2015Aug 31, 2015Nov 4, 20192 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin
1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose

Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin

Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293)
Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293)
Day 1 of Periods 1, 2, and 3:Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293)
Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose
Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin
Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin
Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacokinetic (PK): Area Under the Curve Zero to Infinity (AUC[0-∞]) for LY3314814
Day 4: Predose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours (Cohort A)
PK Profile for Simvastatin: AUC(0-∞)
Day 2 and 36: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours (Cohort A)
PK Profile for Midazolam: AUC(0-∞) Oral and IV Dose
Day 1, 3, 17, 35, and 37: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, and 12 hours (Cohort A)
PK Profile for Donepezil: AUC(0-∞)
Day 1 and 28: predose 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96,120, 216, 288, and 360 hours (Cohort B)
Secondary Endpoints
Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)
Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat
.Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
RosuvastatinEXPERIMENTALPeriod 1: 20 mg rosuvastatin administered once orally (PO)
Lanabecestat + RosuvastatinEXPERIMENTALPeriod 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8
Lanabecestat Reference FastedEXPERIMENTALLanabecestat: 50 mg administered once PO in each of 3 treatment periods.
Lanabecestat Test FastedEXPERIMENTALLanabecestat: 50 mg administered once PO in each of 3 treatment periods.
Lanabecestat Test Non FastedEXPERIMENTALLanabecestat: 50 mg administered once PO in each of 3 treatment periods.
Dabigatran EtexilateEXPERIMENTALSingle dose of dabigatran etexilate administered orally.
Lanabecestat and Dabigatran EtexilateEXPERIMENTALSingle 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.
WarfarinEXPERIMENTALSingle oral dose of 15 mg warfarin on Day 1.
Lanabecestat + WarfarinEXPERIMENTALLanabecestat administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.
Cohort AEXPERIMENTAL500 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 BEXPERIMENTAL5 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
Interventions
NameTypeDescription
LanabecestatDRUGAdministered orally
RosuvastatinDRUGAdministered orally
Dabigatran etexilateDRUGAdministered orally
WarfarinDRUGAdministered orally
SimvastatinDRUG20 mg simvastatin will be administered orally as 1 × 20-mg tablet
MidazolamDRUG500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup
DonepezilDRUG5 mg donepezil will be administered orally as 1 × 5-mg tablet
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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