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AZD8566

Phase 1

Healthy Volunteer Study | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 9, 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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00866385AZD8566 Food Effect/Microtracer StudyPHASE1 COMPLETED 21 — — Mar 1, 2009Apr 1, 2009Jun 9, 20091 United Kingdom
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Study Endpoints
Primary Endpoints
Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food
Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose
Secondary Endpoints
Safety and tolerability of AZD8566 in healthy volunteers in the fed and fasted state by assessment of vital signs, laboratory variables, ECGs and adverse events
Assessments taken during visit 1 and at defined timepoints pre and post dose during visits 2 and 3. Volunteers will be monitored throughout the study for adverse events.
Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose
Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
Intravenous pharmacokinetics
Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Interventions
NameTypeDescription
AZD8566DRUGSingle 6 mg oral solution dose
AZD8566 IV carbon labelledDRUGSingle 10 mcg intravenous carbon-14 microtracer dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of written informed consent * Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG * Females who are permanently or surgically sterile or post-menopausal and males Exclusion Criteria: * History of any convulsions o...

Countries:United Kingdom
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