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AZD6088

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Sep 10, 2009

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 Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00931541AZD6088 Single Ascending Dose StudyPHASE1 COMPLETED 35Jun 1, 2009Aug 1, 2009Sep 10, 20091 United Kingdom
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Study Endpoints
Primary Endpoints
Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)
Sampling occasions during all visits.
Secondary Endpoints
Pharmacokinetics
Intense PK-sampling during 3 pre-defined study days for PK profiling.
Pharmacodynamics
Sampling occasions during 3 pre-defined study days.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AEXPERIMENTALAZD6088 oral solution
BEXPERIMENTALPlacebo oral solution
Interventions
NameTypeDescription
AZD6088DRUGOral solution. Each subject will receive a single-dose of AZD6088.
PlaceboDRUGOral solution. Each subject will receive a single-dose of placebo.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture. * Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by t...

Countries:United Kingdom
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