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IntelliCap

Phase 1

Plasma Concentration | Small molecule | Other |AstraZeneca PLC|Last Updated: Jan 27, 2016

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 Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02025348Explore the Performance of IntelliCap.EARLY_PHASE1 COMPLETED 20 — — Jan 1, 2014Mar 1, 2014Jan 27, 20161 United Kingdom
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Study Endpoints
Primary Endpoints
In vivo performance
Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h

To assess the in vivo performance of the IntelliCap® system by characterizing the plasma concentration of a probe drug (metoprolol)

Secondary Endpoints
Pharmacokinetic parameters
Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment A metoprolol 50mgEXPERIMENTALIntelliCap® capsule Release profile 1 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg).
Treatment B metoprolol 50mgEXPERIMENTALIntelliCap® capsule Release profile 2 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg).
Treatment C metoprolol 50mgEXPERIMENTALIntelliCap® capsule Release profile 3 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg).
Treatment D metorpolol 50mgEXPERIMENTALmetoprolol oral solution 1 mg/mL (dose 50 mg).
Interventions
NameTypeDescription
IntelliCapDRUGDrug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male volunteers aged between 18 and 50 years of age, inclusive. * Subjects with a body weight of at least 50 kg and no more than 100 kg, inclusive. * Subjects with a body mass index (BMI) of 18 - 30 kg/m2, inclusive. BMI = Body weight (kg) / \[Height (m)\]2. * Subjects...

Countries:United Kingdom
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