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AZD1981, current small-particle

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials4
Total Enrollment81
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01311635A Bioavailability Study Comparing 3 Different AZD1981 TabletsPHASE1 COMPLETED 16 — — Apr 1, 2011Jun 1, 2011Jul 7, 20111 Sweden
NCT01058447Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male VolunteersPHASE1 COMPLETED 4 — — Feb 1, 2010Mar 1, 2010Nov 18, 2010 - —
NCT00918398AZD1981 Bioavailability Study of Intravenous (IV) and Oral FormulationsPHASE1 COMPLETED 14 — — Jun 1, 2009Jul 1, 2009Jul 30, 20091 Sweden
NCT00698282Single and Multiple Ascending Doses of AZD1981 in JapanPHASE1 COMPLETED 47 — — Aug 1, 2008Oct 1, 2008Dec 1, 20101 United Kingdom
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Study Endpoints
Primary Endpoints
Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981
Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period.
Pharmacokinetic variables and Radioactivity
Frequent sampling occasions during study days
PK samples for AZD1981 from both blood and urine
Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose.
Adverse events
All the time
Plasma drug concentration
Every hour
Secondary Endpoints
To evaluate basic systemic PK parameters as follows:
PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period
To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight
Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
Frequent sampling occasions during study days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTAL -
Treatment BEXPERIMENTAL -
Treatment CEXPERIMENTAL -
Treatment DEXPERIMENTAL -
1EXPERIMENTAL -
2EXPERIMENTALAZD1981, 514 mg oral solution
3EXPERIMENTALAZD1981, 500 mg oral tablet A
4EXPERIMENTALAZD1981, 500 mg oral tablet B
Interventions
NameTypeDescription
AZD1981, current small-particle tabletDRUG3x100 mg per oral, single dose in fasted state
AZD1981, new small-particle tabletDRUG3x100 mg per oral, single dose
AZD1981, new large-particle tableDRUG3x100 mg per oral, single dose in fasted state
AZD1981DRUGOral tablet, 250 mg, single dose
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive * Have a body mass index between 19-30 kg/m2 and weigh 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...

Countries:SwedenUnited Kingdom
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