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Apriso CAP

Phase 1

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

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

Clinical trial landscape

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 being developed for ulcerative colitis, a form of inflammatory bowel disease. It is a capsule formulation of Apriso 375 mg being studied in healthy volunteers as part of a Phase 1 clinical trial. The drug is not yet approved and remains in clinical development.

Who makes Apriso CAP?

Apriso CAP is being developed by Bausch Health Companies Inc., traded on the New York Stock Exchange under the ticker BHC. The company is conducting clinical research on this formulation for ulcerative colitis, with the drug currently in Phase 1 development.

What phase is Apriso CAP in?

Apriso CAP is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under study for ulcerative colitis.

What clinical trials is Apriso CAP in?

Apriso CAP has one completed clinical trial, NCT03327558, a randomized, double-blind, active-controlled Phase 1 study comparing Apriso 375 mg to the approved Apriso 375 mg capsules in healthy male and female subjects. The trial enrolled 60 participants in the United States.

Is Apriso CAP the same as Apriso?

Apriso CAP is a capsule formulation of Apriso 375 mg, studied in a Phase 1 trial against the approved Apriso 375 mg capsules. While related, Apriso CAP is an investigational version being evaluated for ulcerative colitis, whereas the approved Apriso capsules are already marketed.