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AZD1981 twice daily for 61/2 days

Phase 1

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Mar 7, 2011

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01196689Pharmacokinetics in AdolescentsPHASE1 COMPLETED 21Oct 1, 2010Feb 1, 2011Mar 7, 20111 Sweden
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Study Endpoints
Primary Endpoints
The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCτ, Css,max, Css,trough, and CL/F of AZD1981
0 hours after last dose
Secondary Endpoints
Tolerability and safety assessed by adverse events
During 7 days
Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire
Day 1 and 7
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD1981 100 mg twice daily for 6 ½ days
Interventions
NameTypeDescription
AZD1981 100 mg twice daily for 61/2 daysDRUG100 mg tablets
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Eligibility Criteria
Age Range12 Years — 17 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * A minimum of 6 months documented history of asthma * Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry) Exclusion Criteria: * Any clinically significant disea...

Countries:Sweden
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