Back to resultsSteady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
Primary Purpose
Severe Hepatic Impairment
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
About this trial
This is an interventional treatment trial for Severe Hepatic Impairment
Eligibility Criteria
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.
Sites / Locations
- Valeant Site 01Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rifaximin
Arm Description
Rifaximin 550 mg BID
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax)
Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable
Time of the maximum concentration (Tmax)
Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable
Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval
Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable
Secondary Outcome Measures
Full Information
NCT ID
NCT03818672
First Posted
January 22, 2019
Last Updated
September 7, 2022
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03818672
Brief Title
Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
Official Title
Open Label Study to Evaluate the Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy Subjects and Subjects With Severe Hepatic Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to characterize the steady state plasma
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hepatic Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rifaximin
Arm Type
Experimental
Arm Description
Rifaximin 550 mg BID
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
Rifaximin 550 MG BID
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Description
Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable
Time Frame
7 days
Title
Time of the maximum concentration (Tmax)
Description
Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable
Time Frame
7 days
Title
Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval
Description
Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tendai Merriweather
Phone
9085412720
Email
tendai.merriweather@bauschhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Varsha Bhatt
Organizational Affiliation
Bausch Health Companies
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 01
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
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