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AZD9668

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Other |AstraZeneca PLC|Last Updated: Jan 29, 2013

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-BlindCONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment881
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00949975A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With TiotropiumPHASE2 COMPLETED 838 — — Jul 1, 2009Aug 1, 2010Aug 3, 2012105 United States, Australia +10
NCT01034982AZD9668 Relative BioavailabilityPHASE1 COMPLETED 28 — — Nov 1, 2009Dec 1, 2009Feb 5, 20101 Germany
NCT01035411AZD9668 Relative BioavailabilityPHASE1 COMPLETED 15 — — Nov 1, 2009Dec 1, 2009Jan 29, 20131 Germany
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Study Endpoints
Primary Endpoints
Baseline Pre-bronchodilator FEV1 (L)
Day 1

Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic

End-value Pre-bronchodilator FEV1 (L)
Measured at clinic visits: 1, 4, 8 and 12 weeks

End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

Relative bioavailability (Frel): to assess the relative systemic bioavailability after oral administration of the free base of AZD9668 dosed as a suspension compared to the tosylate salt of AZD9668 dosed as a tablet formulation at two dose levels.
Frequent sampling occasions during the study
Relative bioavailability (Frel): to assess the relative systemic bioavailability after oral administration of a tablet variant of AZD9668 compared to AZD9668 tablets.
Frequent sampling occasions during the study
Secondary Endpoints
Post-bronchodilator FEV1 (L) - Baseline
Day 1
Post-bronchodilator FEV1 (L) - End-value
Measured at clinic visits: 1, 4, 8 and 12 weeks
Pre-bronchodilator FVC (L) - Baseline
Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORAZD9668 active treatment
2ACTIVE_COMPARATORAZD9668 active treatment
3ACTIVE_COMPARATORAZD9668 active treatment
4PLACEBO_COMPARATORAZD9668 placebo treatment
Interventions
NameTypeDescription
AZD9668DRUG2 x 30 mg oral tablets twice daily (bid) for 12 weeks
AZD9668 PlaceboDRUG2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites105

Inclusion Criteria: * Diagnosis of COPD with symptoms over 1 year * Smokers or ex-smokers * Males or post-menopausal females between 40 and 80 years old * Able to use electronic devices Exclusion Criteria: * Past history or current evidence of clinically significant heart disease * Current diagno...

Countries:United StatesAustraliaCanadaGermanyJapanPhilippinesPolandRussiaSlovakiaSouth KoreaTaiwanUkraine
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