Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
Study Details
Study Description
Brief Summary
The primary objective of this study is to characterize the steady state plasma
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Rifaximin Rifaximin 550 mg BID |
Drug: Rifaximin
Rifaximin 550 MG BID
|
Outcome Measures
Primary Outcome Measures
- Maximum observed plasma concentration (Cmax) [7 days]
Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable
- Time of the maximum concentration (Tmax) [7 days]
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 [7 days]
Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Valeant Site 01 | San Antonio | Texas | United States | 78215 |
Sponsors and Collaborators
- Bausch Health Americas, Inc.
Investigators
- Study Director: Lindsey Mathew, Bausch Health Companies
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RFPK4045