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AZD4451

Phase 1

Bipolar Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Aug 1, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01196676Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451PHASE1 COMPLETED 63 — — Aug 1, 2010Apr 1, 2011Aug 1, 20111 United States
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of single ascending oral doses of AZD4451 by assessing AEs, vital signs, physical examinations, neurological examinations clinical laboratory parameters, Columbia Suicide Severity Rating Scale(CSSRS), EEGs and ECGs
Screening to end of study.
Secondary Endpoints
To assess the pharmacokinetics of single ascending oral doses of AZD4451 by maximum plasma concentration (Cmax).
Predose, 30 min, 1 hr, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 30, 48, and 72 hours postdose.
To evaluate and characterize the PK of AZD4451 and its metabolites AZ13263197 and AZ13263195 when given orally in single ascending doses by assessment of drug concentration in urine.
Urine will be collectioned for 72 hours post-dose. Pre-dose to 12 hours, 12-24, 24- 48 and 48-72 hours post-dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD4451
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
AZD4451DRUG1 mg capsules, 5 mg capsules, and 25 mg capsules
PlaceboDRUG1 mg capsules, 5 mg capsules, and 25 mg capsules
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provide a signed and dated, written informed consent prior to any study specific procedures being performed. including the genetic sampling and analyses. If a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit t...

Countries:United States
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