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

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03818672
Collaborator
(none)
18
1
1
48.9
0.4

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

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.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)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 5, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rifaximin

Rifaximin 550 mg BID

Drug: Rifaximin
Rifaximin 550 MG BID

Outcome Measures

Primary Outcome Measures

  1. Maximum observed plasma concentration (Cmax) [7 days]

    Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable

  2. Time of the maximum concentration (Tmax) [7 days]

    Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable

  3. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT03818672
Other Study ID Numbers:
  • RFPK4045
First Posted:
Jan 28, 2019
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2021