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

Bausch Health Americas, Inc.24 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pharmacokinetic

Interventions

rifaximinDRUG

550 mg TID

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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