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IntelliCap

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Jan 27, 2016

IntelliCap development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

IntelliCap clinical trials

IntelliCap · 1 trial · 2 indications

Early Phase 1 1
NCT02025348Explore the Performance of IntelliCap.Plasma Concentration
COMPLETED20 Analytics
EARLY_PHASE1COMPLETED
Explore the Performance of IntelliCap.
Plasma Concentration
NCT0202534820
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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 to 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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Frequently asked questions about IntelliCap

What is IntelliCap?

IntelliCap is an early-phase small molecule developed by AstraZeneca PLC. It has been studied in a single completed Phase 1 trial involving 20 healthy male volunteers in the United Kingdom. The trial examined plasma concentration and pharmacokinetic profile, and the specific therapeutic indication has not been disclosed.

Who makes IntelliCap?

IntelliCap is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the early-phase clinical trial of IntelliCap conducted in the United Kingdom.

What phase is IntelliCap in?

IntelliCap is in Phase 1 development. One early-phase trial, NCT02025348, has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA.

What clinical trials is IntelliCap in?

IntelliCap has been evaluated in one completed clinical trial, NCT02025348, titled "Explore the Performance of IntelliCap." The trial enrolled 20 healthy male volunteers aged 18 years and older in the United Kingdom and assessed plasma concentration and pharmacokinetic profile.

What is IntelliCap used for?

The therapeutic indication for IntelliCap has not been disclosed. Its only completed clinical trial, NCT02025348, evaluated plasma concentration and pharmacokinetic profile in healthy male volunteers rather than a specific disease population, so no approved or investigational use has been publicly stated.

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