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

Severe Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03818672
• Other study ID #: RFPK4045
• Status: Terminated
• Phase: Phase 4
• Start date: January 29, 2019
• Est. completion date: February 2, 2020

Study information

• Verified date: November 2023
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 2, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Diseases
• Severe Hepatic Impairment

Intervention

Drug:
• Rifaximin
Rifaximin 550 MG BID

Locations

Country	Name	City	State
United States	Valeant Site 01	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable	7 days
Primary	Time of the Maximum Concentration (Tmax)	Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable	7 days
Primary	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	7 days