Recent Updates
Recently added Catalysts

Ketoconazole

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 3, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00707551An Interaction Study of Ketoconazole/Verapamil Versus AZD1305PHASE1 COMPLETED 27 — — Jul 1, 2008Nov 1, 2008Dec 3, 20101 Germany
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Pharmacokinetic variables
During all dosing visits
Secondary Endpoints
Adverse events, vital signs, ECG, laboratory variables and physical examination
During the study
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALKetoconazole tablet + AZD1305 Extended Release tablet
2EXPERIMENTALVerapamil Extended Release tablet + AZD1305 Extended Release tablet
3EXPERIMENTALAZD1305 Extended Release tablet
Interventions
NameTypeDescription
KetoconazoleDRUGTablet, administered as repeated doses.
VerapamilDRUGExtended Release tablet, administered as repeated doses.
AZD1305DRUGExtended Release tablet, administered as a single dose.
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * A body mass index (BMI=weight/height2) of 19 to 30 kg/m2 Exclusion Criteria: * Potassium outside normal reference values * ECG findings outside normal range

Countries:Germany
Unlock Eligibility Criteria