Recent Updates
Recently added Catalysts

IntelliCap

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock trial analytics

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.
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about IntelliCap

What is IntelliCap used for?

IntelliCap is an investigational small molecule being studied for its plasma concentration and pharmacokinetic profile. It is in early Phase 1 clinical development, with a completed trial evaluating its performance in healthy volunteers.

Who makes IntelliCap?

IntelliCap is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting early-stage clinical research on this investigational small molecule.

What phase is IntelliCap in?

IntelliCap is in Phase 1 clinical development. One early Phase 1 trial has been completed, and the drug remains investigational, meaning it has not been approved for any use.

What clinical trials is IntelliCap in?

IntelliCap has one completed clinical trial, NCT02025348, titled "Explore the Performance of IntelliCap." This early Phase 1 study enrolled 20 healthy male volunteers in the United Kingdom to assess plasma concentration and pharmacokinetic profile.

Is IntelliCap being studied in healthy volunteers?

Yes, IntelliCap is being studied in healthy volunteers. The completed Phase 1 trial NCT02025348 enrolled 20 healthy male participants aged 18 years and older in the United Kingdom.