Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers

Overview

The primary objective of this study is to determine if rifaximin, administered daily has an effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.

Full Title of Study: “A Phase 1, Single Arm, Open-Label Study to Evaluate the Effect of Rifaximin 550 MG Tablets TID on the Pharmacokinetics of Orally Administered Midazolam in Healthy Male and Female Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2008

Detailed Description

This is a single-site, single-arm, open-label, drug-interaction study that examines the effect of rifaximin (RFX), 550 mg 3 times daily (TID; 1650 mg/day), on orally administered (PO) midazolam (MDZ) 2 mg (administered as a 2 mg dose in 1 mL of midazolam HCL Syrup; 2 mg/mL) when dosed for 7 and 14 consecutive days, respectively.

Interventions

  • Drug: rifaximin
    • 550 mg TID

Arms, Groups and Cohorts

  • Experimental: 1
    • open-label rifaximin 550 mg TID

Clinical Trial Outcome Measures

Primary Measures

  • Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized.
    • Time Frame: 21 to 38 days (including a 21 day screening period)

Secondary Measures

  • Overall safety assessments will include the incidence, intensity, and type of adverse events, and clinically significant changes in the patient’s physical examination, vital signs and laboratory results.
    • Time Frame: 21 tyo 38 days

Participating in This Clinical Trial

Inclusion Criteria

  • Patient is medically normal – Patient has normal laboratory values – Patient has the ability to understand the requirements of the study Exclusion Criteria:

  • HIV – Hepatitis B – Hepatitis C – History of renal, hepatic, endocrine, oncological, gastrointestinal or cardiovascular disease. – History of epilepsy, asthma, diabetes, psychosis, glaucoma or severe head injury.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bausch Health Americas, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • William Lewis, MD, Principal Investigator, Covance CRU, Inc

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