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AZD0837

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
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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
RandomizedCONTROLLEDBiomarker
Total Trials4
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00904800AZD0837 Extended Release (ER) Japan StudyPHASE1 COMPLETED 36 — — May 1, 2009Jun 1, 2009Jul 13, 20091 Japan
NCT00878618Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837PHASE1 COMPLETED 36 — — Apr 1, 2009May 1, 2009Jun 3, 20091 Sweden
NCT00812643Excretion of Radiolabelled AZD0837PHASE1 COMPLETED 8 — — Jan 1, 2009Feb 1, 2009Mar 11, 20091 Sweden
NCT00812344Effect of Ketoconazole on Biliary Excretion of AZD0837PHASE1 COMPLETED 20 — — Dec 1, 2008Mar 1, 2009Dec 3, 20101 Sweden
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Study Endpoints
Primary Endpoints
To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.
All assessments are made at each visit, at least daily, during the study.
To evaluate the pharmacokinetics of AZD0837 and the active metabolite AR-H067637XX for the extended-release test formulation of AZD0837 compared to the ER reference formulation.
Intense PK-sampling during 5 pre- defined study days for PK profiling. In 2 of the study days the subjects will have a breakfast before intake of the Investigational Product.
The amounts of total radioactivity excreted in bile. Metabolic profile of AZD0837 excreted in bile and identification of previously unknown metabolites and the amounts of AZD0837, AR-H069927XX and AR-H067637XX in bile.
Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose.
Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX.
Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose.
Secondary Endpoints
To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects.
Blood samples will be taken before and after study drug administration.
To evaluate the PK of the intermediate metabolite AR-H069927XX
Since the metbolite will be evaluated from the AZD0837-samples the time frame is the same as above.
Safety variables (ECG, pulse, blood pressure, safety lab, physical examination, adverse events)
ECG & physical examination at start and end of study. Pulse and blood pressure predose day 1 and every day 2 h post dose. Adverse events collected during the whole study. Safety lab at a few timepoints but APTT will be checked on 4 h post dose on day 1.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALLow dose
2EXPERIMENTALMiddle dose
3EXPERIMENTALHigh dose
4PLACEBO_COMPARATORplacebo
HABEXPERIMENTALAZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast
HBAEXPERIMENTALAZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast
LABEXPERIMENTALAZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast
LBAEXPERIMENTALAZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast
Interventions
NameTypeDescription
AZD0837DRUGtablet, oral, once daily, 1+5 days
PlaceboDRUGPlacebo
KetoconazoleDRUGtablets, orally, once daily for 3 days
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Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male Japanese subject aged between 20 to 45 years inclusive Exclusion Criteria: * Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2 * Intake of another investigati...

Countries:JapanSweden
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