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AZD9742

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 27, 2012

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 Enrollment119
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01114152AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese SubjectsPHASE1 COMPLETED 35Apr 1, 2010Jul 1, 2010Aug 3, 20101 United States
NCT01064388A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 DaysPHASE1 COMPLETED 36Feb 1, 2010Aug 1, 2010Jun 6, 20121 United States
NCT01030224This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy SubjectsPHASE1 COMPLETED 48Nov 1, 2009Mar 1, 2010Jul 27, 20121 United States
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Study Endpoints
Primary Endpoints
Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
collected prior to treatment, during treatment and follow-up for a total of 18-22 days
Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events.
Secondary Endpoints
Characterize the Pharmacokinetics of AZD9742 in blood and urine
PK-sampling during 14 pre-defined study days for PK profiling
To characterize the Pharmacokinetics of AZD9742 in blood and urine
PK-sampling during 14 pre-defined study days for PK profiling
Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine
Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDose level A, B, C and optional Dose level D and E: single administration and one to three times daily for 6 days (Japanese n=8)
2PLACEBO_COMPARATORplacebo given (2 subjects in each dose group)
AZD9742 IV InfusionEXPERIMENTALActive
Placebo to AZD9742 IV InfusionPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
AZD9742DRUGIV Formulation
PlaceboDRUGIV Formulation
Placebo to match AZD9742DRUGSingle IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)
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Eligibility Criteria
Age Range23 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * female (non-childbearing potential) * Body mass index (BMI) : 17 to 27 kg/m 2 Exclusion Criteria: * History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, ...

Countries:United States
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