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AZD3199 Turbuhaler

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: May 5, 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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00772759Assess Safety, Tolerability and PK of AZD3199 in JapanesePHASE1 COMPLETED 27Oct 1, 2008Feb 1, 2009May 5, 20091 United Kingdom
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Study Endpoints
Primary Endpoints
Safety/Tolerability - adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis)
During the study
Secondary Endpoints
Pharmacokinetic Parameters derived from plasma concentration and optionally urinary excretion of AZD3199.
During residential period
Pharmacodynamic Potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure, and forced expiratory volume in one second (FEV1).
During residential period
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDry powder for oral inhalation
2PLACEBO_COMPARATORDry powder for oral inhalation
Interventions
NameTypeDescription
AZD3199 Turbuhaler®DRUG240, 720 and 2160 μ g, single and multiple (o.d. for 12 days)
Placebo Turbuhaler®DRUGsingle and multiple (o.d. for 12 days)
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Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Be healthy Japanese volunteers, both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for for more than 5 years. * BMI 18 - 27, Weight 50 - 85 kg ...

Countries:United Kingdom
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