Recent Updates
Recently added Catalysts

AZD1940

Phase 1

Low Back Pain | Small molecule | Musculoskeletal |AstraZeneca PLC|Last Updated: Dec 10, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00689780Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940PHASE1 COMPLETED 60Mar 1, 2008Nov 1, 2008Dec 10, 20103 Sweden
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Assessment of adverse events (AEs) occurring during the study, blood pressure (supine and standing), pulse rate, respiratory rate, body temperature, laboratory variables and ECG
Vital signs, laboratory variables and adverse event each day throughout the study Paper printout ECG and/or digital ECG throughout the study
Secondary Endpoints
Assessment of psychometric rating scales ( VAMS, CDR test battery, DEQ, ARCI and Bond-Lader)
Psychometric tests and VAMS (Visual Analogue Mood Scale) throughout the study
To investigate the PK profile (including dose proportionality) of AZD1940 by assessment of plasma concentrations
Bloodsampling Day 1,6, 10 and 15
Plasma levels of midazolam and 4ß hydroxycholesterol and 6β hydroxycortisol:cortisol urine excretion ratio as markers
Bloodsampling at day -1, 14
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD1940 + Placebo
2OTHER -
Interventions
NameTypeDescription
AZD1940DRUGOral solution Multiple ascending dose given orally once daily at day 1-12
MidazolamDRUGOral solution given orally once daily on day -1 and day 14
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * A diagnosis of Chronic Low Back Pain according to Quebec Task force Class 1-3 and an average pain intensity score of 3-9 on NRS(0-10) during the past week. * Clinical normal physical findings, including blood pressure, pulse rate \> 45bpm, ECG (with normal QTcF interval \<450m...

Countries:Sweden
Unlock Eligibility Criteria