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AZD5985

Phase 1

Healthy | 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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00799331Exploratory Study to Assess the Pharmacokinetics of AZD5985PHASE1 COMPLETED 32Nov 1, 2008Feb 1, 2009Jun 9, 20091 Germany
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Study Endpoints
Primary Endpoints
It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985.
Frequent sampling occasions during study days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AEXPERIMENTALAZD5985
BEXPERIMENTALplacebo
Interventions
NameTypeDescription
AZD5985DRUGOral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits.
placeboDRUGOral suspension.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed, written and dated informed consent prior to any study specific procedures. * Healthy male subjects aged 18 to 45 years (inclusive). * Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg. * Be non-smoker or ...

Countries:Germany
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