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ICI176,334-1

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: May 30, 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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01415778Bioequivalence of ICI176,334-1 in Japanese Healthy Male SubjectsPHASE1 COMPLETED 48 — — Aug 1, 2011Dec 1, 2011May 30, 2012 - —
NCT01415791Oral Mucosal Absorption of ICI176,334-1PHASE1 COMPLETED 8 — — Aug 1, 2011Sep 1, 2011May 30, 2012 - —
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Study Endpoints
Primary Endpoints
To investigate the bioequivalence of ICI176,334-1 by assessment of maximum plasma concentration (Cmax)
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of time to Cmax (tmax)
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of area under the plasma concentration curve (AUC)
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 of bicalutamide
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma
Samples are taken at 72 hours after application of the investigational drug
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva
Samples are taken at 72 hours after application of the investigational drug
Secondary Endpoints
To assess the safety by assessment of adverse event
Screening day up to 35 to 42 days (follow-up)
To assess the safety by assessment of vital signs
Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
To assess the safety by assessment of electrocardiograms (ECGs)
Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active 1EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Active 2EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Active 3EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Active 4EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Interventions
NameTypeDescription
ICI176,334-1DRUGSubject will receive single dose of ICI176,334-1
Casodex 80 mg tabletDRUGSubject will receive single dose of Casodex 80 mg tablet
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Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Japanese healthy male subjects aged 20 to 45 years * Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational...

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