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AZD8329

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Mar 2, 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 Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01225939A Study Conducted Over 3 Periods to Look at the Drug in the BodyPHASE1 COMPLETED 18 — — Nov 1, 2010Dec 1, 2010Mar 2, 20111 United Kingdom
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Study Endpoints
Primary Endpoints
Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329.
Information will be collected during 48h after each dose.
Secondary Endpoints
Explore the effect of food on the pharmacokinetics (Tmax, T1/2 and CL/F) of AZD8329 oral solid formulation.
Information will be collected during 48h after dose.
Investigate the safety and tolerability of AZD8329 administered as two different oral formulations.(Safety variables: Adverse events, Vital Signs, Clinical chemistry, Electrocardiogram (p ECG))
Adverse event will be collected from first dose to last visit . Clinical chemistry, Vital Signs and pECG's will be collected at all 5 visits
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALSingle Oral dose AZD8329 tablet (fasting)
2EXPERIMENTALSingle Oral dose AZD8329 solution (fasting)
3EXPERIMENTALSingle Oral dose AZD8329 tablet (Fed)
Interventions
NameTypeDescription
AZD8329DRUGtablet
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5 * suitable veins for cannulation or repeated venepuncture * Subjects should have a body mass index (BMI) be...

Countries:United Kingdom
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