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AZD7268

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jan 29, 2013

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 Enrollment126
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01116011Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male VolunteersPHASE1 COMPLETED 30 — — Apr 1, 2010Jul 1, 2010Dec 15, 20101 Japan
NCT00912353AZD7268 Single Ascending Dose Study in Healthy Japanese SubjectsPHASE1 COMPLETED 56 — — May 1, 2009Oct 1, 2009Jan 29, 20131 United States
NCT00861718Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy VolunteersPHASE1 COMPLETED 40 — — Apr 1, 2009Oct 1, 2009Dec 10, 20091 United States
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Study Endpoints
Primary Endpoints
Investigate the safety and tolerability of AZD7268 by Adverse Events.
From first dosing throughout the treatment period and including the follow-up period
To asses the safety nature and incidence of adverse events, blood pressure, pulse rate, body temperature, physical examination, laboratory assessments (clinical chemistry, hematology, and urinalysis parameters), effects on ECG parameters, EEG recordings,
From screening period to follow-up, 44 days (maiximum).
To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses to healthy male subjects and female subjects of non-childbearing potential.
Safety assessments are made at each visit, at least daily, during the study.
Secondary Endpoints
Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma
Blood samples will be taken from pre-dose until 48 hours post last dose
Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine
Urine samples will be taken from post first dose until 48 hours post last dose.
To characterize the pharmacokinetics of AZD7268 and its metabolite(s) in plasma and urine.
Blood and urine sampling from pre-dose until 72 hrs post dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
AZD7268EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD7268DRUGCapsule, Oral, BID
PlaceboDRUGCapsule, Oral, BID
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Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of Informed Consent * Healthy male subjects, with suitable veins for cannulation or repeated venipuncture Exclusion Criteria: * Inability to understand or cooperate with given information * Any positive result on screening for human immune deficiency virus (HIV), H...

Countries:JapanUnited States
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