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Apriso CAP

Phase 1

Ulcerative Colitis | Small molecule | Gastrointestinal |Bausch Health Companies Inc.|Trials Updated: May 8, 2018

Apriso CAP target and mechanism

ModalitySmall molecule

Also known as Apriso 0.375G ER CAP

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Apriso CAP clinical trials

Apriso CAP · 1 trial · 1 indication

Phase 1 1
NCT03327558Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female SubjectsUlcerative Colitis
COMPLETED60 Analytics
PHASE1COMPLETED
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
Ulcerative ColitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax (Maximum observed plasma concentration)
3 hours after oral dose is taken

Maximum observed plasma concentration levels used for descriptive analysis

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Apriso 0.375G ER CAPEXPERIMENTALApriso 0.375G ER Cap
APRISO 375 mg extended-release capsulesACTIVE_COMPARATORAPRISO 375 mg ER cap

Interventions

NameTypeDescription
Apriso 0.375G ER CAPDRUGER capsule
APRISO 375 mg extended-release capsulesDRUG375 mg extended-release capsules
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female, at least 18 years of age * Body mass index (BMI) between18.5 and below 32.0 kg/m2 (inclusive) * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ECG and labo...

Countries:United States
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Frequently asked questions about Apriso CAP

What is Apriso CAP used for?

Apriso CAP is an investigational small molecule developed for ulcerative colitis, a form of inflammatory bowel disease. It is being studied by Bausch Health Companies Inc. under ticker BHC. The program is in Phase 1 clinical development.

Who makes Apriso CAP?

Apriso CAP is developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is the sponsor of the clinical program for this ulcerative colitis candidate.

What phase is Apriso CAP in?

Apriso CAP is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program has completed one Phase 1 trial with 60 enrolled participants.

What clinical trials is Apriso CAP in?

Apriso CAP has been studied in one completed Phase 1 trial, NCT03327558. The randomized, double-blind, active-controlled study enrolled 60 healthy male and female subjects in the United States and compared APRISO 375 mg against approved APRISO 375 mg capsules.

Is Apriso CAP the same as Apriso 0.375G ER CAP?

Yes, Apriso CAP is also known as Apriso 0.375G ER CAP. Both names refer to the same Bausch Health Companies Inc. product candidate being studied for ulcerative colitis.