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AZD4721

Phase 1

Safety,Plasma AUC and Cmax, Plasma AUC 0-t, t1/2λz, and Tmax | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 25, 2015

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01889160Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose LevelsPHASE1 COMPLETED 44Jul 1, 2013Dec 1, 2013Jun 25, 20151 United Kingdom
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Study Endpoints
Primary Endpoints
Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments, including serial blood neutrophil count
From Screening to follow up ( maximum 7 weeks)
Secondary Endpoints
Description of the pharmacokinetic(PK) profile for in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z).
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Description of the pharmacokinetic(PK) profile for in terms of: area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC(0-24)), from time zero to the time of last quantifiable concentration (AUC(0 last))
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
Description of the pharmacokinetic(PK) profile for in terms of from time zero extrapolated to infinity (AUC), apparent clearance for parent drug estimated as dose divided by AUC (CL/F; AZD4721 only)
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A ActiveEXPERIMENTALAZD4721 Solution
Part A PlaceboPLACEBO_COMPARATORPlacebo for AZD4721
Part B solutionEXPERIMENTALAZD4721 Solution
Part B SuspensionACTIVE_COMPARATORAZD4721 Suspension
Interventions
NameTypeDescription
AZD4721 SolutionDRUG1-9 mg/mL liquid solution
AZD4721 PlaceboDRUGLiquid solution
AZD4721 SuspensionDRUG9 mg/g liquid suspension
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and/or female Caucasian (neither Black/African American nor Japanese) volunteers aged 18-50 years. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG ) 2. Females must have a negative pregnancy test at...

Countries:United Kingdom
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