Status:
TERMINATED
Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Severe Hepatic Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03818672
Start Date
January 29 2019
End Date
February 2 2020
Last Update
November 30 2023
Active Locations (1)
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1
Valeant Site 01
San Antonio, Texas, United States, 78215