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AZD5423

Phase 1

Bioavailability and AUC | Small molecule | Other |AstraZeneca PLC|Last Updated: Jan 14, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01635985A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD5423 When Administered in Different WaysPHASE1 COMPLETED 18 — — Aug 1, 2012Dec 1, 2012Jan 14, 20151 United Kingdom
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Study Endpoints
Primary Endpoints
Pharmacokinetics of AZD5423 delivered by the new dry powder inhaler in terms of: Fpulmonary
Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.
Secondary Endpoints
Pharmacokinetics of AZD5423 following i.v administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss
Blood samples taken pre-dose and at 5, 10, 25, 30, 35 and 45 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48, 72 and 96 hours post dose.
Pharmacokinetics of AZD5423 following oral administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss
Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36 and 48 hours post dose.
Pharmacokinetics of AZD5423 following oral inhalation by Spira, I-neb, Turbuhaler and New Dry Powder Inhaler in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss
Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD5423 iv
2EXPERIMENTALAZD5423 inhalation, Spira
3EXPERIMENTALAZD5423 inhalation I-neb
4EXPERIMENTALAZD5423 oral
5EXPERIMENTALAZD5423 inhalation Turbuhaler
6EXPERIMENTALAZD5423, New Dry Powder Inhaler
Interventions
NameTypeDescription
AZD5423DRUGsolution for injection, administered as intravenous infusion Corr to total dose of 250 µg AZD5423
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or women of non-childbearing potential aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture * Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive) * B...

Countries:United Kingdom
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