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Part 2 - AZD2423

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jan 23, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment74
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00977626Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy VolunteersPHASE1 COMPLETED 74Oct 1, 2009May 1, 2010Jan 23, 20121 United Kingdom
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Study Endpoints
Primary Endpoints
Investigate the safety and tolerability of AZD2423 in young and elderly subjects following multiple ascending doses at steady state and, if possible, estimate the maximum tolerated dose if within the predefined exposure limits (Part 1 and 2 only).
Part 1:Safety samples taken frequently throughout the study at screening, d-1 and from days 2-16 and at the follow up visit. Part 2: Safety samples taken frequently throughout the study at screening, d-1 and from days 1-9 and at follow up visit.
Secondary Endpoints
Characterize multiple dose PK of AZD2423 and assess time required to reach steady state, degree of accumulation and time dependency of PK (Part 1 and Part 2 only). Characterize single and multiple dose PK of AZD2423 in elderly subjects (Part 1 only)
Part 1: PK will be taken days 1-14 inclusive and at follow-up, with a full PK day on Day 1 and 14. Part 2: PK samples taken on days 1-9 and at follow up visit. Day 1 and 8 is a full PK day.
To investigate concentration of AZD2423 in cerebrospinal fluid (CSF) (Part 2 only).
Part 2: CSF Samples will be taken on day 8 at 4 and 24 hours post dose.
Investigate the PK of tablet formulation compared to oral solution, effect of food compared to fasting, and investigate the safety and tolerability of oral solution and tablet formulation of AZD2423 in young subjects after admin. of single dose (Part 3)
Safety samples taken frequently throughout the study at screening, d-1 and from days 2+3 7-10, 14, 16+17 and at the follow up visit. PK samples will be taken on days 1-4, 8-11, 15-18 and at the follow up visit.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part 1 AZD2423 or PlaceboEXPERIMENTALAZD2423 or Placebo Oral Solution, multiple dosing during 10-14 days
Part 2 - AZD2423EXPERIMENTALAZD2423 Oral solution, multiple dosing
Part 3 - AZD2423EXPERIMENTALAZD2423 Oral solution single dosing or AZD2423 Oral solution, single dosing - With Food or AZD2423 Oral solution, single dosing - Fasting Condition.
Interventions
NameTypeDescription
Part 1 - AZD2423 or PlaceboDRUGAZD2423 Oral Solution, multiple dosing during 10-14 days or Placebo Oral Solution, multiple dosing during 10-14 days
Part 2 - AZD2423DRUGAZD2423 Oral solution, multiple dosing
Part 3 - AZD2423DRUGAZD2423 Oral solution, single dosing or AZD2423 Oral solution, single dosing - With Food or AZD2423 Oral solution, single dosing - Fasting Condition.
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Eligibility Criteria
Age Range20 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy male and non-fertile female subjects aged ≥20 to ≤55 years inclusive and healthy male and female subjects aged ≥65 to ≤80 years inclusive with suitable veins for cannulatio...

Countries:United Kingdom
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