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Rifaximin Novel Formulation

Phase 1

Undisclosed | Small molecule | Other |Bausch Health Companies Inc.|Trials Updated: Jun 18, 2021

Rifaximin Novel Formulation development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment124

FDA Designations

No designations recorded

Rifaximin Novel Formulation clinical trials

Rifaximin Novel Formulation · 1 trial · 1 indication

Phase 1 1
NCT04529811Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy VolunteersHealthy Volunteers
COMPLETED124 Analytics
PHASE1COMPLETED
Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy Volunteers
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants with adverse events
Up to 18 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Formulation 1 - Low DoseEXPERIMENTALRifaximin Formulation 1 Capsules
Formulation 1 Capsules - Mid DoseEXPERIMENTALRifaximin Formulation 1 Capsules
Formulation 1 Capsules - High DoseEXPERIMENTALRifaximin Formulation 1 Capsules
Formulation 1 Capsules - Max DoseEXPERIMENTALRifaximin Formulation 1 Capsules
Formulation 1 Capsules - PlaceboPLACEBO_COMPARATORPlacebo Formulation 1 Capsules
Formulation 2 - Low DoseEXPERIMENTALRifaximin Formulation 2 Capsules
Formulation 2- Mid DoseEXPERIMENTALRifaximin Formulation 2 Capsules
Formulation 2 - High DoseEXPERIMENTALRifaximin Formulation 2 Capsules
Formulation 2 - Max DoseEXPERIMENTALRifaximin Formulation 2 Capsules
Formulation 2 - PlaceboPLACEBO_COMPARATORPlacebo Formulation 2 Capsules
Formulation 3 - Low doseEXPERIMENTALRifaximin Formulation 3 Capsules
Formulation 3 - Mid doseEXPERIMENTALRifaximin Formulation 3 Capsules
Formulation 3 - High doseEXPERIMENTALRifaximin Formulation 3 Capsules
Formulation 3 - Max doseEXPERIMENTALRifaximin Formulation 3 Capsules
Formulation 3 - PlaceboPLACEBO_COMPARATORPlacebo Formulation 3 Capsules

Interventions

NameTypeDescription
Rifaximin Novel FormulationDRUGRifaximin Novel Formulation
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The participant has the ability and willingness to sign a written informed consent, is either male or female aged between 18 and 65 years, inclusive, at the time of informed consent, is in good general health, and has a body mass index (BMI) at least 18 kg/m2 and at most 34 kg...

Countries:New Zealand
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Frequently asked questions about Rifaximin Novel Formulation

What is Rifaximin Novel Formulation?

Rifaximin Novel Formulation is an investigational small molecule developed by Bausch Health Companies Inc. (ticker BHC). It is a new version of rifaximin being studied in a Phase 1 clinical program. The specific therapeutic indications for this novel formulation have not been disclosed.

Who is developing Rifaximin Novel Formulation?

Rifaximin Novel Formulation is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is responsible for the clinical development of this asset.

What phase is Rifaximin Novel Formulation in?

Rifaximin Novel Formulation is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 1 program has completed one trial.

What clinical trials is Rifaximin Novel Formulation in?

Rifaximin Novel Formulation has been evaluated in one completed Phase 1 trial, NCT04529811. This randomized, placebo-controlled study assessed the safety and pharmacokinetics of novel rifaximin formulations in 124 healthy volunteers in New Zealand. No active trials are currently listed for this asset.

What is Rifaximin Novel Formulation used for?

The intended therapeutic use of Rifaximin Novel Formulation has not been disclosed. The completed Phase 1 trial was conducted in healthy volunteers to evaluate safety and pharmacokinetics, not in a patient population with a specific disease.