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AZD3839

Phase 1

Alzheimer's Disease | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Apr 6, 2012

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01348737Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy VolunteersPHASE1 COMPLETED 72 — — Jun 1, 2011Nov 1, 2011Apr 6, 20121 United Kingdom
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Study Endpoints
Primary Endpoints
Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1)
Part 1 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 3) approximately 15 days
Number of Adverse Events as a measure of Safety and tolerability of AZD3839 (Part 2)
Part 2 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 4) approximately 20 days
Secondary Endpoints
Time at which maximum concentration occurs in AZD3839 (Part 1)
pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3)
Maximum observed concentration of AZD3839 in plasma (Part 1)
Part 1 - pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3)
Time at which maximum concentration occurs in AZD3839 (Part 2)
Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the Administration. May be taken at the follow-up visit (Visit 4)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AZD3839EXPERIMENTALOral Treatment
AZD3839 PlaceboPLACEBO_COMPARATOROral Treatment
Interventions
NameTypeDescription
AZD3839DRUGSingle Oral Dose
AZD3839 PlaceboDRUGSingle Oral Dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female volunteers of non-childbearing potential aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture * Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weigh between 50 kg and 100 kg (inclusive) * Cre...

Countries:United Kingdom
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Competitive Landscape -Alzheimer's Disease 68 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC, Xanomeline/Trospium Chloride, Xanomeline Enteric, BMS-986446
Eli Lilly and CompanyLLY13PHASE3Donanemab, Dexamethasone, Remternetug, Mevidalen, LY3954068
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3buntanetap/posiphen
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Novartis AG Sponsored ADRNVS2PHASE2VHB937, NIO752
Merck & Co., Inc.MRK2PHASE2MK-1167, MK-2214
GSK plc Sponsored ADRGSK2PHASE2GSK4527226
Cognition Therapeutics, Inc.CGTX2PHASE2CT1812
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Lantheus Holdings IncLNTH2PHASE3Nilotinib BE, PI-2620
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, LLCIGC1PHASE2IGC-AD1-Active
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288, ALN-APP
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT-
Denali Therapeutics Inc.DNLI1PHASE1DNL628
AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
Alzamend Neuro, Inc.ALZN1PHASE1ALZN002 .
Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
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