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AZD1981

Phase 1

Drug Interaction | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 29, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01254461A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of PravastatinPHASE1 COMPLETED 30Feb 1, 2011Apr 1, 2011Apr 29, 20111 Sweden
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Study Endpoints
Primary Endpoints
Pharmacokinetics for pravastatin measured by Cmax and AUC
Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B
Secondary Endpoints
AUC
PK sampling will be performed on Day 1, period A and on Day 7-8, period B
AUCτ
PK sampling will be performed on Day 7 and Day 8, period B
Safety and tolerability
Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
Interventions
NameTypeDescription
AZD1981DRUG100 mg per oral, twice daily for 8 days
pravastatinDRUG40 mg, once daily at Day 1, period A and Day 8, period B
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male volunteers aged 18 to 55, inclusive * Have a body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg, inclusive * Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to screening * Volunteers must be willing ...

Countries:Sweden
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