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

NCT03818672 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: RFPK4045
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Severe Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

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

  7 days

• Time of the Maximum Concentration (Tmax)

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

  7 days

• 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

Study Arms (1)

Rifaximin

EXPERIMENTAL

Rifaximin 550 mg BID

Drug: Rifaximin

Interventions

Rifaximin DRUG

Rifaximin 550 MG BID

Rifaximin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Valeant Site 01

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health Americas, Inc

Varsha.Bhatt@bauschhealth.com

7072851528

Study Officials

• Varsha Bhatt

  Bausch Health Companies

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 28, 2019
• Study Start: January 29, 2019
• Primary Completion: February 2, 2020
• Study Completion: February 2, 2020
• Last Updated: November 30, 2023
• Results First Posted: November 30, 2023

Record last verified: 2023-11

Locations

US (1)