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AZD2516

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Mar 4, 2010

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment118
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00972049Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy SubjectsPHASE1 COMPLETED 40 — — Sep 1, 2009Dec 1, 2009Mar 4, 20101 Japan
NCT00892944An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516PHASE1 COMPLETED 6 — — Apr 1, 2009Oct 1, 2009Oct 28, 20091 Sweden
NCT00754715Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy VolunteersPHASE1 COMPLETED 72 — — Sep 1, 2008Dec 1, 2008Dec 15, 20081 Sweden
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Study Endpoints
Primary Endpoints
Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG
Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 3 and follow up visit 3
Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy
1 Month: Baseline and 3 PET examinations
Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
From first to last visit
Secondary Endpoints
Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects
Blood sampling at defined timepoints during residential period and follow-up
Safety and tolerability of AZD2516 by adverse events, vitals signs, ECG, body temperature and laboratory variables
Assessed at each visit from baseline to follow-up visit
To investigate the Pharmacokinetics of AZD2516
1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALCapsule administered once orally
2PLACEBO_COMPARATORCapsule administered once orally
AZD2516EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD2516DRUGCapsule administered once orally. Specific dose depends on dose panel.
PlaceboDRUGCapsule administered once orally
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Eligibility Criteria
Age Range20 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Weight between 45 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2 * Japanese males aged between 20 to 45 years old (young) and Japanese males or females aged between 65 to 80 years old (elderly) Exclusion Criteria: * History of previous or ongoing somatic or psy...

Countries:JapanSweden
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