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Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects

NCT ID: NCT03818672

Last Updated: 2023-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2020-02-02

Brief Summary

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The primary objective of this study is to characterize the steady state plasma

Detailed Description

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The primary objective of this study is to characterize the steady state plasma PK of rifaximin (550 mg BID) in subjects with severe hepatic impairment (MELD 19 to 25 and MELD \>25), as well as healthy subjects with normal hepatic function.

Conditions

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Severe Hepatic Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rifaximin

Rifaximin 550 mg BID

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

Rifaximin 550 MG BID

Interventions

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Rifaximin

Rifaximin 550 MG BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically impaired subjects will have a MELD score of \>25.

Exclusion Criteria

* Subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients and/or vehicles used in the formulation, or any other clinically significant allergies.
* Subject has participated in an investigational drug or device study within 30 days prior to Day 1 (Baseline).
* Subject has any concurrent illness (other than liver cirrhosis), disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the investigator.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Varsha Bhatt

Role: STUDY_DIRECTOR

Bausch Health Companies

Locations

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Valeant Site 01

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RFPK4045

Identifier Type: -

Identifier Source: org_study_id