Recent Updates
Recently added Catalysts

Phase IIb formulation

Phase 1

Uncontrolled and Persistent Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jun 25, 2015

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01989520Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069PHASE1 COMPLETED 36 — — Jan 1, 2014Apr 1, 2014Jun 25, 20151 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Description of pharmacokinetics of AZD5069 and its metabolite in terms of area under plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration and extrapolated to infinity (AUC(0-last) and AUC)
Samples taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

Curve taken during each of the 5 treatments

Description of pharmacokinetics of AZD5069 and its metabolite in terms of observed maximum plasma concentration (Cmax), plasma concentration measured at 12 hours (C12h), Cmax/C12h ratio, Cmax/AUC ratio, terminal rate constant (λz)
Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

Curve taken during each of the 5 treatments

Description of pharmacokinetics of AZD5069 and its metabolite in terms of terminal half-life (t½λz), time to reach maximum plasma concentration (tmax)
Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

Curve taken during each of the 5 treatments

Description of pharmacokinetics of AZD5069 and its metabolite in terms of apparent systemic clearance (CL/F) (AZD5069 only), and apparent volume of distribution (Vz/F) (AZD5069 only)
Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

Curve taken during each of the 5 treatments

Secondary Endpoints
Description of effect on neutrophils in terms of circulating neutrophil numbers reported as absolute circulating neutrophil counts (ANC). The minimum absolute neutrophil count (ANCmin) and the time to ANCmin (ANCtmin)
Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
Description of effect on neutrophils in terms of mean of ANC values from predose to 24 hours postdose (ANCmean), the minimum of the ANC ratio values (ANCmin,ratio)
Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
Description of effect on neutrophils in terms of the mean of ANC ratio values calculated baseline to 24 hours post dose (ANCmean,ratio)
Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTALPhase IIb formulation
Treatment BEXPERIMENTALPutative phase III formulation
Treatment CEXPERIMENTALSlow dissolution variant 1
Treatment DEXPERIMENTALSlow dissolution variant 2
Treatment EEXPERIMENTALOptional treatment that may use one of 3 45 mg (intermediate dissolution variant) of AZD5069
Interventions
NameTypeDescription
Phase IIb formulationDRUGSingle oral dose 45mg AZD5069
Putative phase III formulationDRUGSingle oral dose 45mg AZD5069
Slow dissolution variant 1DRUGSingle oral dose 45mg AZD5069
Slow dissolution variant 2DRUGSingle oral dose 45mg AZD 5069
Test treatment EDRUGTablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and/or female volunteers aged 18 to 50 years (inclusive). 2. Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening. 3. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum (min) w...

Countries:United Kingdom
Unlock Eligibility Criteria