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

Phase 4

Terminated

• Conditions: Severe Hepatic Impairment
• Interventions: Drug: Rifaximin

• Registration Number: NCT03818672
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-28
• Study Start: 2019-01-29
• Primary Completion: 2020-02-02
• Study Completion: 2020-02-02
• Status Verified: 2023-11
• Results First Submitted: 2023-11-10
• Results First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Results First Posted: 2023-11-30
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rifaximin	Rifaximin	Rifaximin 550 mg BID

Primary Outcome Measures

Name	Time	Method
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
Time of the Maximum Concentration (Tmax)	7 days	Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable
Maximum Observed Plasma Concentration (Cmax)	7 days	Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable

Trial Locations

Locations (1)

Valeant Site 01; 🇺🇸 San Antonio, Texas, United States